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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

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. 

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Medical Affairs

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

Warehouse & Customer Support Coordinator

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Warehouse & Customer Support Coordinator

Location: San Diego

LinkedIn: https://www.linkedin.com/jobs/view/3782265457/?capColoOverride=true

 

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.


The Warehouse & Customer Support Coordinator located in Vista, CA will report to the Director of Customer Operations and be responsible for ensuring the efficient and secure handling of our innovative hemodialysis system. As a Warehouse & Customer Support Coordinator, you’ll have a unique role of providing tier 1 customer support and serving as a dedicated customer resource and liaison for issue resolution. You will provide exceptional customer support by answering incoming calls and emails, perform basic troubleshooting steps for the device and gather necessary information for the engineering team to accurately diagnose issues, understand root causes and apply appropriate solutions. The other dynamic of this role is manage the inventory transactions of a warehouse including accepting inbound shipments, performing incoming acceptance procedures, performing inventory management activities, and the preparation and coordination of outbound shipments to our customers.


Duties & Responsibilities:

Tier 1 Customer Support:

·        Provide exceptional and timely tier 1 customer support to address inquiries, process orders, resolve issues, and assist customers with technical or clinical questions          related to our medical device.

·        Effectively manage inbound calls, emails, and other communication channels to ensure customer inquiries are addressed promptly and professionally.

·        Maintain a deep understanding of our device, operations, and services to provide accurate and helpful information to customers.


Customer Liaison for Product Issues:

·        Act as a dedicated point of contact for customers, ensuring their concerns and issues are addressed with empathy and professionalism.

·        Collaborate with internal cross-functional teams, including technical support and product engineering, to resolve complex product-related issues and coordinate          solutions.

·        Liaise with field-based customer support teams including field service and clinical training

·        Keep accurate records of customer interactions and report trends or recurring issues to the product development team for continuous improvement.


Shipping and Receiving:

·        Process incoming and outgoing shipments, including accurate documentation and coordination with carriers and couriers.


Inventory Management:

·        Maintain accurate inventory records, conduct regular stock counts and ensure the timely replenishment of stock levels.


Quality Control:

·        Inspect incoming and outgoing shipments for quality and compliance per company standards.


Organization and Layout:

·        Maintain an organized and efficient warehouse layout, optimizing space and ensuring a clean, safe working environment.


Safety Compliance:

·        Adhere to all safety protocols, including the proper handling and storage of medical devices and the use of personal protective equipment (PPE).


Compliance:

·        Ensure all warehouse activities comply with company policies and relevant regulations, including those pertaining to medical device storage and transportation.


Minimum Qualifications:

·        High school diploma/GED or work experience equivalent (Bachelor's degree in a related field is a plus).

·        2+ years of experience in warehouse coordination or a similar role.

·        2+ years of experience in a customer support, customer success, or project coordination role.

·        Active certification to operate a forklift and understanding of safety regulations and best practices in a warehouse setting is required.

·        Experience with SaaS based software systems and CRMs and ERPs and experience in inventory management.


Preferred Qualifications:

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

·        NetSuite experience a plus.


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


Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Will require walking, primarily on a level surface for periods of time throughout the day. The employee will be required to stand, walk, climb or balance, stoop, kneel, crouch or crawl and talk or hear. Proper lifting techniques will be required to lift up to 75lbs.


Working Environment:

This position primarily works in a warehouse environment. It requires frequent sitting, standing, lifting, carrying, and walking. Daily use of a computer and other computing and other digital devices is required.


Travel:

·        No air travel necessary for this position


Hourly Range: $23.96 – $30.76 DOE

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