Director, Systems, Electrical and ATE Engineering

The Director of Systems, Electrical, and Automated Test Engineering will guide cross-functional teams to ensure the successful design, testing, and validation of medical devices that meet the highest standards of safety, efficacy, and regulatory compliance. The role requires technical expertise in systems engineering, electrical engineering, and automated testing, combined with exceptional leadership skills and a track record of innovation in the field of active implantable devices. Responsibilities include determining stakeholder needs and requirements, systems requirements architecture, design, implementation, integration, verification and validation processes.

Essential Duties and Responsibilities

• Use Systems Engineering methods and tools to develop systems engineering products such as requirements decomposition, system architecture; specifications, systems engineering and program plans, interfaces, risk assessment and mitigation, validation and verification planning, overall integration, etc.
• Apply interdisciplinary, collaborative approaches to plan, coordinate, design, develop and verify complex systems solutions to drive integration of hardware and software components ensuring seamless functionality and performance.
• Define system architecture solutions by working with diverse disciplines including ME, EE, Firmware, and Software teams, ensuring scalability, reliability, and performance.

• Develop verification & validation master test plans and oversee internal and external testing efforts to ensure user needs as well as product requirements are met.
• Lead the development of automated test systems for R&D, manufacturing, and quality assurance purposes, and quickly resolve production issues.
• Drive the design, development, and validation of advanced electronic circuits for active implantable medical devices.

• Create departmental strategies and specific objectives and develop budgets, policies, and procedures.
• Lead and mentor the systems, electrical, and automated test engineering teams, fostering a culture of innovation, collaboration, and excellence.
• Recruit, train, and retain top engineering talent.

Qualification Requirements

Experience

• Minimum 10 years of experience in developing medical devices.
• 5 years of experience managing, building and leading teams.
• In-depth knowledge of complex medical device electromechanical system design

Knowledge/Skills/Abilities

• Strong understanding of medical device development processes, regulations, and quality standards.
• Deep knowledge of relevant standards such as ISO 14971, IEC 60601-1, ISO 14708, as well as ISO 62366.
• Proven track record of successfully managing complex, cross-functional projects from initiation to completion.
• Hands-on experience with automated test platforms, hardware/software integration, and manufacturing processes.
• Excellent leadership, communication, and interpersonal skills.
• Exceptional problem-solving abilities and the capacity to make decisions under pressure.
• Outstanding communication skills, including presentation and written communications.
• Ability to work in a fast-paced, team environment, meet deadlines, and prioritize and balance work for multiple individuals.
• Intrinsically motivated, and detail oriented with profound problem-solving abilities.

Education

• Bachelor's degree in engineering; advanced degree preferred.

Physical Demands

• Varied sitting, standing and walking
• Ability to lift and carry 50lbs. or less

Position Details

The position is based in San Mateo, CA. Hybrid arrangements are possible.