Bright Uro
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. 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 . 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.
#J-18808-Ljbffr
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. 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 . 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.
#J-18808-Ljbffr