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Joining a Series-B stage startup in one of the most exciting MedTech spaces means you will have the opportunity to help re-chart the journey of patients with kidney disease.
 
Apply online and explore your potential role on our mission-driven team.
Engineering

Principal Electrical Engineer

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

 

The Principal Electrical Engineer will have an exciting opportunity to architect and develop novel electrical systems for hemodialysis devices in a fast-paced design environment. You'll collaborate with a cross-functional team to develop our flagship product from concept through commercialization. This role requires your thorough understanding of electrical engineering principles and practices. Additionally, the role involves performing technical planning, system integration, verification and validation, cost and risk analysis, and supportability and effectiveness analyses for total systems. You’re expected to be a hands-on engineering expert but also a technical leader, who drives the continuous improvement of innovation, quality, delivery and productivity within the R&D organization.

Duties & Responsibilities:

·        Provides solutions to various issues in creative and effective ways.

·        Directs the application of existing principles and guides development of new policies and ideas within the function.

·        Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. 

·        Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.

·        Take full responsibility for all aspects of electrical design to ensure product features, performance and quality are met within the cost budget and delivered on time.

·        Identifies and specifies electronic subsystems and boards.

·        Documents and analyzes design requirements for implementation.

·        Design, model, simulate and test complex electronic circuits, subsystems and systems.

·        Create schematic drawings, support PCB layout, generate BOMs and build packages, and coordinate with contract manufacturer on board fabrication and assembly.

·        Diagnose sand proposes solutions for electrical system issues.

·        Support system integration and troubleshooting, verification and validation, including safety, EMC and reliability.

·        Apply risk, failure analysis, and root cause analysis as required within the engineering discipline.

·        Works with production to ensure manufacturability and testability of electrical designs.

Ensure all the design activities and documents meet the regulatory and QMS requirements.

Qualifications and Requirements:

·        Bachelor’s degree ​​in science or engineering ​ ​

·        Minimum 12 years of related experience in complex electromechanical system design for Medical Devices

·        Proficient with electronic circuits design, including power, analog and digital components and applications.

·        Proficient with EDA tools to do schematics and layout design.

·        Proficient with lab instruments to do measurement and troubleshooting.

·        Understanding of design for manufacturability and reliability, with full product life cycle experience (medium to high volume).

·        Knowledge of IEC60601series standards, experience with test and troubleshooting of electrical safety and EMC.

·        Understanding of Medical Device QMS and design control, familiar with PDM/PLM system and change control process.

·        Excellent communication and presentation skills 

·        Show high initiative and collaborative, be self-motivated, and have ability to act independently on technical matters.

·        Experience in hemodialysis/hydraulic system design, familiar with motor driver design, sensor signal processing is a plus.

·        Experience with projector technical management is a plus.

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Salary Range: $155,000-$185,000 DOE

Principal Software Engineer

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Principal Engineer will be responsible for architecting, designing, developing, and maintaining user interface(s), user experience, and application software for our medical devices. The Principal Software Engineer will be required to work with cross-functional teams including systems, hardware, regulatory experts, and clinical specialists to ensure that our software solutions meet the highest standards of quality, safety, and performance.

We offer a competitive salary and benefits package, as well as opportunities for career growth and development. If you are passionate about developing software for medical devices and enjoy working in a collaborative and dynamic environment, we encourage you to apply for this exciting opportunity.

Duties & Responsibilities:

·        Leads and contributes to development of company objectives and principles to achieve goals in creative and effective ways.

·        Focuses on providing thought leadership and works on broader organization projects, which requires understanding of wider business.

·        Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. 

·        Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.

·        Recognized internally as a subject matter expert. May direct the activities of others.

·        Architect, design, develop and debug User interface for medical device(s).

·        Develop and maintain documents for compliance with FDA regulations for class C medical device software

·        Software development on Linux or similar OS.

·        Develop UI software using Design patterns.

Qualifications and Requirements:

·        Bachelor’s or Master’s degree in computer science, Electrical Engineering, or related fields

·        Minimum of 8-12 years of experience in software development, preferably in the medical device industry

·        Strong experience in user interface and user experience design

·        Experience with application software development in C++ / Python/

·        Experience with creating user personas, user journey maps, and other UX design artifacts to empathize with the target audience.

·        Experience with embedded UI development, preferably using Qt.

·        Familiarity with IEC 62304 standard for medical device SDLC

·        Experience in developing device drivers on Linux or similar OS.

·        Strong knowledge of software design principles, design patterns, algorithms, data structures, and object-oriented programming

·         Experience with Agile/Scrum development methodologies

·         Excellent problem-solving and analytical skills

·         Excellent verbal and written communication skills

·         Knowledge of, Qt, UX, C/C++, Python, Yocto,  Squish Coco, SonarQube, Linux

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Salary Range: $155,000-$185,000 DOE

Senior Electrical Engineer

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Senior Electrical Engineer will develop electrical systems for hemodialysis devices. Additionally, the role involves planning and coordinating detailed phases of electrical engineering activities for the assigned project, and participating sub-system integration, verification and troubleshooting; Responsibilities include planning and performing tests and providing resolutions; creating and reviewing documentation and related drawings; designing electrical components, circuits or sub-systems of moderate difficulty;

Duties & Responsibilities:

·        Resolves and assesses a wide range of issues in creative ways and suggests variations in approach.

·        Complete knowledge and full understanding of engineering, principles, and practices

·        Devises solutions based on limited information and precedent and adapts existing approaches to resolve issues.

·        Uses evaluation, judgment, and interpretation to select the right course of action.

·        Enhances relationships and networks with  senior internal/external partners who are not familiar.

·        Conducts engineering activities of electrical design to ensure product features, performance and quality are met within the cost budget and delivered on time.

·        Identifies and specifies electronic subsystems and boards.

·        Documents and analyzes design requirements for implementation.

·        Designs, models, simulates and tests electronic circuits, subsystems and systems.

·        Creates schematic drawings, guides PCB layout, generates BOMs and build packages, and coordinates with contract manufacturer on board fabrication and assembly.

·        Diagnoses and proposes solutions for electrical system issues.

·        Supports system integration and troubleshooting, verification and validation, including safety, EMC and reliability.

·        Applies risk, failure analysis, and root cause analysis as required within the engineering discipline.

·        Works with production to ensure manufacturability and testability of electrical designs.

·        Administrate electrical lab equipment, tools and materials; support board and cable rework and assembly; ensure the lab activities meet the safety and 5S requirements.

Qualifications and Requirements:

·        Bachelor’s degree in science or engineering.

·        Minimum 5 years of related experience or 3 years and a master’s degree.

·        Familiar with electronic circuits design, including power, analog and digital components and applications.

·        Familiar with EDA tools to do schematics and layout design.

·        Familiar with lab instruments to do measurement and troubleshooting.

·        Good hand-on skills of reworking and cabling.

·        Understanding of design for manufacturability and reliability.

·        Knowledge of IEC60601 series standards, experience with test and troubleshooting of electrical safety and EMC is a plus.

·        Understanding of Medical Device QMS and design control, familiarity with PDM/PLM system and change control process is a plus.

·        Good communication and reporting skills.

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.​

Salary Range: $119,000-$140,000 DOE

Senior Systems (Integration) Engineer

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Senior System Integration Engineer will be responsible for designing, implementing, and managing the integration of sub-system designs in hardware, firmware, and software applications within our medical device system. This role requires a deep understanding of medical device regulations, strong technical skills, and the ability to work collaboratively with different teams to ensure seamless system integration. You will leverage your extensive expertise to drive the design and validation of complex systems, ensuring compliance with regulatory standards and industry best practices.

Duties & Responsibilities:

·          ​​​Responsible for coordinating with functional and cross functional team members to ensure project milestones are achieved.

·          Responsible for strategizing and development of integration test plans to ensure product requirements specifications are met. Coordinate integration testing activities with internal teams and external partners to ensure V&V testing deliverables  are met.

·          Lead the integration testing of hardware sub-systems to ensure seamless interaction and functionality within the overall system.

·          Oversee and conduct a wide range of tests, including functional, performance, reliability, and environmental tests on complex medical device systems (e.g.  60601-1, 60601-1-2, HALT).

·          Lead investigations into complex technical issues or failures related to hardware/software sub-components. Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions.

·          Diagnose and troubleshoot complex hardware issues, working collaboratively with cross-functional teams to implement solutions.

·          Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.

Qualifications and Requirements:

·          Bachelor’s or Master’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or a related field.

·          Minimum of 5-7 years of experience in systems engineering or related field, preferably in medical devices.

·          Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.

·          Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.

·          Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.

·          Proficiency in engineering tools (e.g., SolidWorks, Minitab).

·          Proficiency in scripting languages (e.g. Python, Matlab) and other software languages.

·          Proficiency in using test equipment such as oscilloscopes, multimeters, spectrum analyzers, and logic analyzers.

·          Familiarity with various communication protocols (e.g., I2C, SPI, UART, Ethernet).

·          Knowledge of hardware design and PCB layout.

·          Strong problem-solving skills and the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.

·          Experience in risk management methodologies (e.g., FMEA, fault tree analysis) and their application to medical device development and regulatory compliance.

·          Proven experience in conducting thorough analysis and evaluation of technical requirements, feasibility, and risks, developing comprehensive engineering solutions and mitigation strategies.

·          Experience in system architecture design and control system design.

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.​

Salary Range: $119,000-$140,000 DOE

Senior Systems (Validation) Engineer

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Senior Systems Validation Engineer will play a critical role in ensuring that our products are intuitive, safe, and effective for end-users. This individual will lead human factors research and design activities, collaborate with cross-functional teams, and apply human-centered design principles to influence product development from concept through production. You will leverage your extensive expertise to drive the design and validation of complex systems, ensuring compliance with regulatory standards and industry best practices.

Duties & Responsibilities:

·          Plan and execute clinical use and user need validation studies to assess product performance in real-world settings.

·          Work  closely with clinical partners and stakeholders to design studies that accurately reflect clinical environments and workflows.

·          Collect  and analyze data to validate the safety and effectiveness of products in clinical use.

·          Document findings and provide recommendations for design improvements based on clinical use validation results.

·          Communicate user needs and insights to cross-functional teams to inform design decisions.

·          Ensure all human factors engineering activities comply with FDA Human Factors Engineering Guidance.

·          Conduct formative and summative evaluations as specified by FDA human factors guidelines to identify and mitigate potential use errors.

·          Create detailed human factors engineering reports to support FDA submissions, including use-related risk analyses, validation test protocols, and test results.

·          Collaborate with regulatory affairs teams to ensure all human factors documentation meets FDA requirements.

·          Collaborate with product designers, engineers, and other stakeholders to incorporate human factors principles into the design process.

·          Create and maintain documentation for human factors activities, including user profiles, task analyses, use scenarios, and risk assessments.

·          Responsible for coordinating with functional and cross functional team members to ensure project milestones are achieved.

·          Share  knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team

Qualifications and Requirements:

·          Bachelor’s or Master’s degree in Human Factors Engineering, Bioengineering, Industrial Engineering, or a related field.

·          Minimum of 5-7 years of experience in human factors engineering, preferably in medical devices.

·          Proven track record of leading human factors activities in product development cycles.

·          Expert knowledge of human factors standards and guidelines (e.g. FDA Human Factors Guidance, IEC 62366, HE75).

·          Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.

·          Proficiency in human factors and usability testing tools and methodologies.

·          Experience with user interface design and evaluation.

·          Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and  stakeholders at all levels of the organization.

·          Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.

·          Experience in risk management methodologies (e.g., Use FMEA) and their application to medical device development and regulatory compliance.

·          Experience in user need and human factors engineering for medical device systems is a plus.

 

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.​

Salary Range: $119,000-$140,000 DOE

Software V&V Engineer Intern

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Software V&V Engineer Intern

Location: Irvine, CA 

Employment Type: Non-Exempt (Hourly)

Duration: May through August up to 29 hours per week

Salary Range Hourly: $22-$24 DOE

 

Company & Job Overview: 

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems. 

Diality is seeking a Software V&V Engineering Intern majoring in Computer Science, Software Engineering, Electrical Engineering, or in a related field. As a Software V&V Engineering Intern, you will support any software verification tasks as needed. This internship will provide opportunities to also develop soft skills as you work cross-functionally with many experienced engineers and gain insights on how to navigate your early career decisions.  

If you possess the following and want to make a meaningful impact, we invite you to explore this opportunity. 

Responsibilities:

·                    Support test automation using Python/Qt.

·                    Support test execution for dry-run and formal run.

·                    Conduct Bug verifications.

·                    Review and update test protocols to align with software requirements.

    

Minimum Qualifications: 

·                    Currently in the process of obtaining/obtained Bachelor's degree majoring in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or in a related field.

·                    Proficient in Python development

·                    Familiar with Windows and Linux environments

·                    Familiar with Git and Jira

·                    Demonstrates fast learning and self-motivation

 

Preferred Qualifications: 

·                    Possesses critical thinking skills

·                    Willingness to learn and follow directions

·                    Team player who organized and detail-oriented

·                    Proficient in Python skills

·                    Familiar with working in Windows and Linux environment

·                    Fast learner and self-motivated

 

Working Environment: 

·                    Onsite in Irvine Office

·                    Up to 29 hours/week

Travel: 

·                    No travel expectations for this position. 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

 

The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. 

 

Diality is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status under applicable laws. If you require accommodation for a disability during any stage of the recruitment process, please let us know. We appreciate the unique skills, experiences, and perspectives that each candidate brings to our team and are excited to explore the opportunities that working together can bring. 

Finance

Senior Manager, Accounting

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

Diality is seeking a highly skilled and experienced Senior Accounting Manager to lead our accounting function and support our financial planning and analysis (FP&A) activities. As a pivotal member of our finance team, you will ensure the accuracy and integrity of financial reporting, compliance with regulatory requirements, and provide insightful financial analysis to drive business decisions.

​​​  Accounting Responsibilities:

  • Lead monthly and annual financial statement close processes in accordance with US GAAP
  • Determine all necessary journal entries including payroll, fixed assets, prepaids, leases, taxes, insurance, warranties, and 401(k)
  • Maintain GL accounting reconciliations including bank and credit card, current & long term assets, current & long term liabilities and equity
  • Ensure purchase orders and invoices are properly recorded on GL by expense type and department
  • Review financial statements for accuracy
  • Provide monthly financial reporting of actual results including final income statement and balance sheet in a variety of formats
  • Manage accounts payable and accounts receivable, including review and approval processes
  • Run payroll on a semi-monthly basis and coordinate with HR function regarding people processes
  • Oversee and lead the annual financial statement audit process with external auditor
  • Lead the income and R&D tax credit preparation with external tax preparer
  • Coordinate and lead sales and use tax compliance including registration, filing, and remittance
  • Lead management of equity and stock option data in Carta
  • Assist in managing, maintaining, and enhancing the NetSuite ERP

Financial Planning & Analysis Responsibilities

     
  • Learn the Company’s forecast approach and develop     understanding of forecast model and its integration with accounting and     accounting POs / invoices  
  • Partner with the Senior     FP&A Manager to ensure accounting information and impacts are included     in the forecast model(s)
  • Assist the Senior FP&A     Manager with analysis of actual versus forecast results
  • Protect organization's value by keeping information confidential
        

Qualifications and Requirements:

  • Bachelor’s degree in     accounting or finance
  • Certified Public Accountant     (CPA)
  • Possess at least 5 years of     accounting experience and progressive management responsibility
  • Proficient in managing     accounting systems; with a required knowledge of NetSuite
  • Strong knowledge of     accounting principles and US GAAP
  • Excellent problem solving and     analytical skills
  • Advanced proficiency in     Microsoft Office applications, particularly Excel
  • Proven management skills and experience

Physical Demands:

  • Sustained periods of time sitting in a sedentary light office position with high frequency typing and computer use
  • Sitting at adesk utilizing a computer 

Working Environment:

  • Primarily remote work on a remote team
  • Travel to headquarters (Irvine, CA) as necessary

Salary Range: $127,000-$150,000 DOE

Marketing
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Medical Affairs

Clinical Specialist

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Clinical Specialist is responsible for the co-ordination and implementation of clinical trials and studies, ensuring adherence to regulatory requirements and maintaining data integrity and patient safety standards. Additionally, this role carries cross-functional responsibilities that extend to commercialization efforts, bridging clinical development with market readiness and product launch strategies

Duties & Responsibilities:

·          ​​​Provides guidance to teams within the scope of established company policies.

·          Lead comprehensive training programs for investigative sites, ensuring understanding and compliance with study protocols, procedures, and regulatory  requirements.

·          Conduct hands-on training sessions, ensuring trial site personnel are well-versed on protocol design and proficient in device operation.

·          Lead ongoing training and support to sites throughout the duration of the clinical trials, addressing queries and conducting training sessions as needed.

·          Implement strategies for ongoing education and support, ensuring clinical trial site personnel remain updated on any potential design changes, software updates,  and/or protocol revisions.

·          Collaborate with site staff to facilitate efficient patient recruitment and enrollment strategies, ensuring alignment with study timelines and goals.

·          Implement initiatives to overcome enrollment challenges, providing support and guidance to sites as needed.

·          Collaborate seamlessly across clinical trial activities and commercialization efforts to provide comprehensive support for the expanding organization.

·          Collaborate across departments, including Medical Affairs, Clinical Operations, Marketing, and R&D, to streamline efforts and enhance coordination.

·          Contribute to new product development within the organization through research and subject matter expertise.

·          Identify key product attributes for market expansion and new clinical applications, recognizing emerging opportunities driven by clinical needs.

·          Provide subject matter expertise for regulatory exchanges with medical societies, enhancing scientific communication.

·          Contribute to medical writing and educational activities, including abstracts, presentations, white papers, educational assets, the preparation of clinical  documents, study design protocols, and other related tasks as required.

·          Establish and maintain contacts with external partners such as university groups, KOLs, investigators, patient advocacy groups, industry groups, consultants, and  other applicable medical professionals including Contract Research  Organizations (CRO’s).]

·          Act as a clinical reviewer of advertising, promotional material, and upstream marketing escalation point for Diality, including but not limited to medical related questions/issues from Diality Sponsored projects.

Qualifications and Requirements:

·          Registered Nursewith a minimum of 5 years of clinical experience in nephrology with proven experience and proficiency across  multiple care settings and modalities.

·          Possess working understanding of regulatory requirements in the medical device industry such as the Medical Device Directive 93/42/EEC, ISO 14155, and ICH guidelines. 

·          Possess the ability to ensure compliance throughout product development and launch.

·          Familiarity with Good Clinical Practices (GCPs) guiding clinical trial conduct.

·          Proven ability to collaborate across various departments, including engineering, marketing, and regulatory, to align clinical affairs with overall business objectives.

·          Demonstrates proficiency in both independent work and collaborative teamwork.

·          Enthusiastic about contributing to a dynamic fast-paced team, demonstrating adaptability, and a commitment to continuous learning and enhancement.

·          Possess excellent written and spoken communication skills.

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        Ability to occasionally travel domestically and internationally

Salary Range: $97,000-$155,000 DOE

Vice President, Medical Affairs

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Diality Inc., a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment.

We are looking for a Vice President, Medical Affairs who will leverage experience as a strategic scientific/medial leader to build and lead a high-performing Medial Affairs Organization. Reporting to the CEO, this newly created position will ensure effective medical and scientific partnerships with relevant healthcare providers and patient stakeholders in support of all Diality's regulatory approvals and commercialization efforts.

Essential Duties, Responsibilities, and Expectations

Revenue Recognition Responsibilities

  • Define and establish a Medical Affairs vision and strategy for Diality, building an operational Medical Affairs Organization to support the launch of all current and future programs supporting expansion of Diality's hemodialysis system's use into the home environment and other markets with a small, nimble team of top medical talent to build an integrated Medical Affairs function.
  • Establish and oversee relevant systems and processes to support business needs and ensure compliant, consistent, and ethical operations reflecting the values     of the organization.
  • Lead all clinical trial activity the organization participates in, including study planning, design, execution of key pivotal trials, compliance, and audits.
  • Develop Educational programs involving Internal Educations, Physicians Patients and Compliance.
  • Lead Scientific Communications management with publication strategies, abstracts, manuscripts, podium presentations, and actively participate and present on the podium in relevant scientific meetings and educational events.
  • Manage unrestricted grants, medical information, health economics and outcomes research, and investigator-initiated trials that meet key strategic needs of the company.
  • Lead the clinical operations team to cover Device safety, Clinical Data Management and Biostatistical analysis internally or externally as appropriate.
  • Collaborate with the commercial organization to develop a comprehensive post market approval research strategy to support our product’s value proposition     (clinical and healthcare economic) in targeted clinical settings and develop a strategy for communicating our clinical and healthcare economic evidence to external stakeholders with the commercial team.
  • Key Opinion Leader management through the company’s clinical advisory board (CAB) and study steering and publication committees.
  • Establish and maintain contacts with external partners such as university groups, KOLs, investigators, patient advocacy groups, industry groups and consultants.
  • Evidence Based Medicine knowledge and competitive landscape management.
  • Act as the primary clinical reviewer of advertising, promotional material, and upstream marketing escalation point for Diality, including but not limited to medical related questions/issues from Diality Sponsored projects.
  • Act as the primary clinical escalation point for Quality and provide strategic input for R&D and New Business Development.
  • Working with the head of marketing develop a customer-relationship management platform, that includes identifying, engaging, and managing relationships with dialysis key thought leaders; major national and international dialysis organizations; dialysis patient advocacy groups; University, VA and DOD dialysis departments, and similar international relationships.
  • Lead the development and adoption of processes to accommodate new or changing external requirements in support of medical affairs activities, keeping current with regulations and requirements in the global environment including regulatory affairs authorities.

Qualifications & Requirements

  • An experienced Medical Affairs leader with 10+ or more years of medical device or -pharma industry experience with a strong background in Medical Affairs, particularly in the U.S.
  • Significant Medical Affairs experience in nephrology is required and should hold an active US Medical License and have a working knowledge of the US dialysis     industry.
  • Have previously built or expanded a Medical Affairs department with additional capabilities and experience driving successful launch and post-launch     medical/scientific product support throughout the life cycle is preferred.  
  • Comfortable in a fast-paced and evolving environment and have demonstrated ability to align the Medical Affair function with the growth of a company or     organization.
  • Work effectively in a small team environment and can roll up your sleeves to ensure all department goals are achieved.
  • An inspirational people leader recognized for building and managing high-performing cross-functional teams.
  • Naturally collaborative medical leader who can drive exceptional cross-functional partnerships and scientific exchange with diverse internal and external     stakeholders.
  • Strong compliance mindset and excellent understanding of relevant GCP, ICH and FDA/ EMA regulations.
  • Excellent written and spoken English communication skills.

Base Salary

$273,961/yr - $365,000/yr

Exact compensation may vary based on skills, experience, and location.

Operations

Manager, Strategic Sourcing

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Manager, Strategic Sourcing

Location: Hybrid; Irvine, Ca

 

About Us:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

As a Strategic Sourcing Manager, you will play a crucial role in optimizing our procurement processes, driving cost savings, and maintaining positive supplier relationships. Your expertise in purchasing procedures, strong interpersonal and communication skills, problem-solving abilities, and meticulous organizational skills will be essential in achieving our strategic sourcing objectives.

Duties & Responsibilities:

·        The role is responsible for developing and executing our sourcing strategy including aspects of supplier development and on-going performance management and business needs. This includes developing and fostering strong relationships with suppliers, negotiating terms and conditions, and leading business reviews with suppliers to drive improved supplier service levels while adhering to quality standards.  

·        Develop, manage, and lead supply chain strategy to support COG reduction, supporting ongoing manufacturing and product development while partnering with key contract manufacturing partners and internal stakeholders.  

·        Partner with peers in the Supplier Quality to drive supplier performance to best in class standards through continuous improvement and ensure suppliers can support new product development projects and product launches and growth.  

·        Plan, lead, and execute supplier management and development projects and activities(including sourcing, price negotiating, contract management, cost reducing and managing improvement projects with suppliers) with accountability for successful completion of all project deliverables.  

·        Provide direction and guidance to cross functional teams and partners (e.g., Manufacturing Engineering, R&D, Supplier Quality, etc.) and Contract Manufacturer partners to execute larger supply chain projects and/or initiatives with high complexity.  

·        Perform variety of analyses to assess business risks and opportunities with a moderate level of financial relevance (e.g., limited global impact, product line) to drive supply chain strategies.  

·        Identify process improvement opportunities, respond to business requirements, design implementation strategies, and solutions, develop test scenarios and drive overall implementation of the change and/or improvements.  

·        Monitor and track global and local issues and provide risk mitigation strategies to minimize disruption of supply chain.  

·        Supervise daily procurement activities.

·        Support supplier audits and maintains the Approved Supplier List

·        Develops strategies and processes to ensure purchased goods comprising Diality Product remain in compliance with REACH, RoHS, and other applicable regulations.  

·        Collaborate with Diality quality engineers and suppliers to resolve quality issues. 

·        Responsible for ensuring Supplier response and resolution to reported Quality issues, including CAPA.

Minimum Qualifications:

·       Bachelor’s Degree in math, science, or engineering.  

·       10+years related work experience.  

·       7+years’ work experience in an operations/supply chain role within an FDA regulated environment in the medical device industry or medical field.  

·       New Product Introduction and Life Cycle Management experience. 

·       MS Office proficiency and able to quickly learn new software systems.  

Preferred Qualifications:

·        Knowledge of medical devices and healthcare industry best practices a plus

·        NetSuite experience a plus.

·        Ability to identify and implement new technologies.   

·        Adaptable to meet rapidly changing priorities and exercise a high degree of business judgment and sound reasoning. Self-starter; self-motivated, results and performance driven.  

·        Six Sigma Black Belt or Lean Expert Certification is a plus.  

·        Demonstrated expertise in purchasing procedures and policies to ensure compliance and efficiency in sourcing activities.  

·        Strong communication and interpersonal abilities, including negotiation and relationship management skills to foster productive relationships with suppliers and stakeholders.  

·        Proficient problem-solving capabilities to identify and resolve sourcing challenges.  

·        Strong analytical and critical thinking skills to make informed decisions.  

·        Exceptional organizational skills to manage procurement processes efficiently.  

·        Keen attention to detail to ensure accuracy and thoroughness in all sourcing activities.  

·        Excellent facilitation and presentation skills.  

·        Able to multi-task a variety of duties and work requests. 

·        Understanding of production processes, materials, and strategies to achieve quality and cost targets. 

Skills & Abilities:

·        Strong interpersonal and communication skills, both written and verbal.

·        Ability to work independently, solve problems, and make decisions.

·        Strong organizational skills and attention to detail.

·        Excellent communication and teamwork skills

·        Ability to work in a fast-paced environment

Working Environment:

This position primarily works in an office, laboratory, and manufacturing facility setting.

Travel:

·       Up to 25%

Salary:

$118,000 - $135,000/yr

Quality and Regulatory
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Sales and Support

Technical Support Manager

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Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Technical Support Manager (TSM) will be a subject matter expert, working directly with our Diality employees (both field and office based) and external customers. The TSM will collaborate with Field Service, Customer Service, Engineering, and Clinical teams. The ​TSM​will lead the efforts to educate on the optimal use of our Moda-flx Hemodialysis System. This pivotal role encompasses managing technical support operations, crafting, and executing comprehensive training programs, and ensuring our users experience seamless, effective care enabled by our technology. The ideal candidate is someone passionate about improving patient care through education, support, and the smart use of data and technology.  As the TSM is the first level contact from the field, the ideal candidate should provide best-in-class customer support.  Additionally, the TSM will establish success KPI metrics, track progress, and drive the team to resolve as many technical calls remotely as possible. 

Duties & Responsibilities:

·       ·Work closely with Service and Support team to ensure proper alignment of the Service onboarding program.

·        Ensure effective onboarding activity completion and develop insights that can be used by the Service and Support teams for continuous improvement. 

·        Coach new hires through learning curves while creating a safe and effective learning environment.  

·        Create a continual learning program that aligns with service career progression. 

·        Interface with directly with Diality’s Systems, Software and Mechanical engineering groups when appropriate to resolve technical issues for customers   

·        Provide instruction and materials for Contracted Biomedical Engineering training programs.  

·        Serve as a subject matter expert (SME) for the development of technical and training content for internal and external teams. 

·        Provide detailed feedback to cross-functional departments including Product Support, and Engineering regarding performance, serviceability, and customer feedback. 

·        Manages Tech Support team and advises team on various complex matters.

·        Service Upgrade Communications: Efficiently coordinate and distribute updates on service upgrades, ensuring patients and healthcare providers stay informed about the latest improvements to our dialysis solutions, fostering seamless adoption and enhanced care. 

·        Documentation Compliance and Management: Charged with the creation and ongoing maintenance of comprehensive product and service documentation, strictly adhering to Regulatory and Quality standards to ensure full compliance and accuracy. 

·        Engineering Collaboration for Product Development: Actively collaborates with the Engineering team throughout product development cycles, advocating for hardware and software service requirements.

·        Leading Knowledge Management Implementation: Spearheads the development and execution of a comprehensive Learning Management System (LMS) strategy, aligning with cross-functional stakeholders.

·        Innovative Training Solutions: Implements cutting-edge training solutions that utilize technology to boost learning outcomes. This includes the adoption of blended learning approaches, gamification techniques, and mobile learning platforms to create an engaging and effective educational experience for users.

Qualifications and Requirements:

·        Bachelor's degree in healthcare, education, engineering, science, or related fields. 

·        3-5 years of Dialysis Technical Experience required either from a manufacturer or a service provider in the areas of biomedical engineering. 

·        At least 5 years’ experience in Field Service Support of Medical Devices. 

·        Strong technical acumen with the ability to quickly learn, understand, and teach complex software and systems

·        Possess the ability to incorporate best practices in technology integration into training. 

·        Experience in evaluating training effectiveness through metrics and feedback to continuously improve training content and delivery methods. 

·        Proficient and adept in training technical material, applications, and processes, including using a CRM use specific to document and track Service and Support Interactions.

Physical Demands:

·        Sustained periods of time standing and sitting in a laboratory​ 

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

Working Environment:

·        Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

·        25-30%

Salary Range: $105,000-$125,000 DOE

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