Director of Research Development (Software)

About the Role

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

• Production deployment
• Manage production infrastructure
• 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