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.

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Physical Demands:

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

·        Sitting at a desk utilizing a computer 

·        Some lifting of <25 points

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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.

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

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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.

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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.

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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

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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

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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;

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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.

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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

‍

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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.

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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.

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‍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

‍

‍

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.

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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

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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.​

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

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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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