We have developed a functional assessment for bladder health. Our wireless, catheter-free system received FDA clearance for two system generations, has supported 900+ patients, and is scaling commercially in the U.S.
We have partnered with our CEO and Manager of Corporate Administration to hire our Head of R&D.
This software expert will be a player-coach, shaping the next phase of growth.
This role will own software engineering (still writing code), DevOps, documentation, cybersecurity, and software quality while leading an internal team.
Our Head of R&D Engineering is a senior technical and people leader responsible for defining and executing our R&D engineering strategy across firmware, software, mechanical, and systems engineering disciplines.
This role owns end-to-end product development from concept through commercialization, ensuring delivery of safe, reliable, high‑quality medical devices that meet clinical, regulatory, and business requirements.
In this role, you will partner closely with Quality & Regulatory, Manufacturing, and Clinical teams to maintain design control rigor, risk management discipline, and audit readiness, aligned with the SOC 2 Trust Services Criteria and applicable medical device regulations. You will play a key role in ensuring our products meet the highest standards for safety, reliability, compliance, and security as we grow.
This role is hybrid or on‑site in Irvine, California , and requires a hands‑on leadership presence.
Responsibilities
- Manage software engineering product lifecycle, from specifications and architecture through verification, validation, and commercialization
- Establish and maintain scalable, compliant R&D processes aligned with design controls, risk management, and secure development processes
- Provide Hands‑On strategic and operational leadership, spanning firmware, software, cybersecurity, and commercial product deployment functions
- Manage collaboration with external development partners, including outsourced software development, cybersecurity, and cloud service providers
- Ensure engineering activities meet applicable regulatory and quality requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, SOC‑2, and related standards
- Lead system architecture definition and cross‑disciplinary integration across FW/SW/EE, ensuring performance, safety, reliability, and cybersecurity considerations are embedded by design
- Drive system‑level risk analysis, hazard mitigation, verification, and validation strategies to support patient safety and regulatory submissions
- Partner cross‑functionally with Quality, Regulatory Affairs, Manufacturing, Clinical, and Product teams to support audit readiness, traceability, and continuous improvement
- Build, mentor, and scale a high‑performing engineering team, fostering a culture of accountability, technical rigor, and collaboration
- Manage commercial production infrastructure operations, including uptime, capacity planning, incident response, and SLA management
- Establish clear engineering metrics, development plans, and resource strategies to support company growth and aggressive development timelines
- Review, approve, and maintain comprehensive technical documentation, including system requirements, design outputs, traceability matrices, and technical risk assessments
- Support executive leadership with technical strategy, roadmap planning, and risk‑based decision‑making
- Stay current on emerging technologies, medical device best practices, and evolving regulatory and security requirements
- Perform other related duties as assigned by the CTO or executive leadership
Qualifications
- Bachelor’s degree in Engineering (Electrical, Computer, Biomedical, or related field); Master’s degree preferred.
- 12+ years of experience in software, firmware, and embedded device development, with management experience in a medical device company
- Proven success in integrating complex, multi‑disciplinary medical device systems
- Prior startup experience required, with the ability to operate effectively in fast‑paced, resource‑constrained environments
- Proven experience leading R&D engineering teams and complex product development programs through commercialization
- Strong working knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and related guidance
- Experience implementing and maintaining engineering processes that support audit readiness, data integrity, access controls, and operational resilience consistent with SOC 2 principles
- Excellent leadership, communication, and cross‑functional collaboration skills
- Ability to balance strategic vision with hands‑on technical and operational execution