Join The Team

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

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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

Senior Electrical Engineer

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.

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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:

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

Senior Systems (Integration) Engineer

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.

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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:

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

Senior Systems (Usability/Human Factors) Engineer

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

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Working Environment:

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

Finance

No positions available. Please check back.

Marketing

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Medical Affairs

Clinical Specialist

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

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Working Environment:

Travel:

· Ability to occasionally travel domestically and internationally

‍Salary Range: $97,000-$155,000 DOE

Operations

No positions available. Please check back.

Quality and Regulatory

Director, Regulatory Affairs

The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products. The Regulatory Affairs Director is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the United States and other countries. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product teams. The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR.

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Duties & Responsibilities:

• Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements as appropriate. Supports overall regulatory strategy during product development, manufacturing, market launch, and post-market surveillance.

• Plans and prepares regulatory submissions for new products and product changes to ensure timely approval for clinical studies and market release that include, but are not limited to, the following:

a. US FDA Investigational Device Exemption (IDE)

b. US FDA 510(k)

c. CE Marking under EU MDR

d. Product amendments to existing regulatory approvals/clearances

• Serves as the primary contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies, when needed, directly or in coordination with local country representation.

• Represents Diality in cross-industry regulatory initiatives.

• Responsible for obtaining and maintenance of, but not limited to, the following:

a. Local, State and National Regulatory licensing and registration renewals

b. Import/Export Permits

• Assesses product and manufacturing changes and develops regulatory assessments for each market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs) if appropriate.

• Provides assistance and regulatory guidance regarding product labeling, marketing materials and social media.

• Provides oversight for Regulatory processes and systems. Facilitate and support the implementation of various Regulatory process improvement projects by working directly with key stakeholders to accelerate market access routes and ensure compliance. Lead compliance initiatives relating to Regulatory requirements.

• Supports Quality System projects and activities such as, but not limited to, the following:

a. Complaint Handling

• Supports Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting.

• Provide Oversite and acts as the primary interface with regulatory and other party certification agencies in Product Recalls, Field Related activities and Corrections and Product adverse event reporting collaborate with and supported by Director of Quality.

• Leads inspections/audits by the notified body or other international regulatory Agencies by producing requested documents or answering any inquiries for information.

• Supports the Director, Quality during internal and external (i.e. FDA, etc.) Quality inspections/audits.

• Participates in and review risk management activities/documents and ensure compliance with ISO 14971.

• Monitors product development, manufacturing, and post-market data to ensure appropriate updates to the risk management, design history, technical files, and post-market surveillance reports are incorporated in a timely manner.

• Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity.

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Qualifications and Requirements:

• Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ years of medical device regulatory affairs experience.

• Certification in regulatory affairs (RAC) preferred.

• 2+ years of Regulatory Affairs leadership in a small/start-up company environment, as demonstrated by previous employment roles and responsibilities.

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Experience and Required Skills:

• Demonstrated excellence in developing global regulatory affairs strategies for medical products.

• Strategic thinker, strong leadership and interpersonal communication skills, assertiveness, strong technical background, strong analytical skills, well organized, and excellent negotiation, and project management skills as a regulatory lead on projects.

• US and EU medical device regulatory submission experience required.

• Previous experience interacting directly with FDA is required.

• Hands-on experience with 510(k) and Technical File/Design Dossier submissions.

• Product development team experience.

• Experience reviewing and approving technical documentation.

• Broad based technical knowledge and skills in diverse areas of business such as Engineering, Operations, Quality, Marketing, Clinical Research, etc.

• Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory authorities is a plus.

• Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars

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Knowledge & Abilities:

• Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment.

• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.

• Knowledge and understanding of other foreign country regulations and international device registration a plus.

• Good knowledge of clinical evaluation and investigation of medical devices.

• Excellent interpersonal skills including ability to interact with a high degree of diplomacy.

• Excellent problem-solving, applied thinking and technical writing skills.

• Excellent communication and organization skills required.

• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.

• Expertise in Microsoft Office and Adobe Acrobat applications.

• Familiarity with dialysis and end-stage renal disease is a plus.

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Physical Demands:

• Prolonged periods of sitting at a desk and working on a computer.

• May be expected to lift 15 pounds at times.

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Working Environment:

• Office or work-station environment

• Remote work environment is also an option for this position

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Travel:

• Ability to travel (domestic and international) as required, approximately 10%

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Salary Range: $199,000 - $230,000 DOE

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Sales and Support

Technical Support Manager