Senior Director of R&D Engineering

About Bright Uro:

Bright Uro is a fast-growing medical device company dedicated to developing innovative urology solutions that meaningfully improve patients’ lives. We operate at the intersection of cutting-edge engineering, clinical impact, and rigorous regulatory standards. Our culture is hands-on, collaborative, and mission-driven—ideal for leaders who thrive in startup environments and want to build products that matter.

About the Role:

The Senior Director of R&D Engineering is a senior technical and people leader responsible for defining and executing Bright Uro’s 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 Bright Uro grows.

This role is on-site in Irvine, California, and requires hands-on leadership presence.

Duties and Responsibilities:

• Provide strategic and operational leadership for R&D Engineering, spanning firmware, software, electronic, and devops functions.
• Own the end-to-end engineering lifecycle for medical device development, from early concept and architecture through verification, validation, and commercialization.
• Establish and maintain scalable, compliant R&D processes aligned with design controls, risk management, and SOC 2 Trust Services Criteria (Security, Availability, Confidentiality, Processing Integrity).
• Ensure engineering activities meet applicable regulatory and quality requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, 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.
• Establish clear engineering metrics, development plans, and resource strategies to support company growth and aggressive development timelines typical of a startup environment.
• 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 to continuously strengthen Bright Uro’s R&D capabilities.
• Perform other related duties as assigned by the CTO or executive leadership.

Required 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 management experience in medical device company.
• Advanced coding skills in Python and TypeScript.
  
• 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.

Nice to Have:

• Direct experience with urology, minimally invasive therapeutic devices, or digital health platforms.
• Flutter coding skills.
• Exposure to cybersecurity, data protection, or connected medical device architectures.
• Experience supporting regulatory submissions and inspections.

Physical Requirements:

• Ability to work extended amounts of time standing or sitting based on projects and priorities.
• Ability to lift up to 25 lbs.