Sr. Manager, Clinical Research Engineering
On-siteSunnyvale, California, United States
Sunnyvale, California, United StatesOn-siteFull TimeSenior LevelMedical DeviceEnterprise
Full TimeSenior LevelEnterpriseMedical Device
Job Summary
Lead teams of Clinical Research Engineers in designing and developing robotic systems that improve clinical outcomes, guiding programs from early concept through commercial launch. Define clinical needs and requirements, assess risks, and architect pre-clinical evaluation protocols to support regulatory submissions and first-in-human trials. Manage feasibility, pilot, and pivotal clinical trials while translating physician feedback into actionable engineering requirements. Collaborate with engineers, clinicians, and stakeholders to establish clinical performance objectives and drive innovation strategy.
Required Qualifications
- Fluent in medical and procedural terminology with strong applied knowledge of human anatomy.
- Expertise in complex robotic systems, instrumentation, and associated software algorithms.
- Leadership with consistent high performance and emotional intelligence, drive to be continual learner
- Extensive experience in operating room or interventional suite environments, including direct collaboration with physicians and clinical staff.
- Demonstrated ability to capture, interpret, and integrate clinical feedback into product design and risk management processes.
- Strong mechanical and technical aptitude with exceptional spatial reasoning and understanding of complex mechanical systems.
- Advanced analytical skills to design, execute, and interpret clinical and pre-clinical studies, drawing actionable conclusions.
- Proven ability to lead multi-disciplinary teams, influence decision-making, and resolve critical issues with urgency and precision.
- Deep familiarity with FDA and MDR Design Control processes, risk management, and regulatory compliance.
- Exceptional communication skills—verbal, written, and presentation—tailored to diverse technical and executive audiences.
- Self-directed leader who thrives in dynamic environments, operates effectively under pressure, and maintains a high level of accountability.
- Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or a closely related technical discipline
- 10+ years of progressive experience and 3-5 years as people manager in clinical engineering, product development, and/or translational research within the medical device industry, including significant exposure to complex capital equipment, robotic systems, or advanced minimally invasive technologies
- Demonstrated track record of leading cross-functional programs from early concept through regulatory clearance and commercial launch, with deep experience in both pre-clinical and clinical phases
- Proven ability to integrate clinical, technical, and market insights into product requirements, risk assessments, and development strategies, driving innovation while ensuring compliance with global regulatory standards
- Must be available to work full-time and commute/relocate to Sunnyvale, CA
- Up to 30% travel. Some international travel will be required.
- Must show current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- Advanced degree (M.S. or Ph.D.)
- Experience with on-site clinical trial support
- Experience with commercial product launch
- Familiar with intellectual property development and patent assessment
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