R&D Manager: Minimally Invasive Medical Devices

Surf Search Inc.; Carlsbad (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Surf Search Inc. seeks an R&D Manager to lead engineering and product development for new minimally invasive medical devices, guiding projects from concept to commercialization.

The role blends hands-on engineering with strong project leadership and cross-functional collaboration across regulatory, quality, manufacturing, and clinical teams. The ideal candidate has a track record in regulated Class II/III medical devices, strong design, V&V, risk management, and excellent communication.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
• 7+ years in developing regulated Class II/III medical devices through full lifecycle.
• 3+ years managing engineers and technical personnel.
• Experience with catheter-based, minimally invasive or small-scale disposable devices.
• Strong understanding of mechanical design, materials and manufacturing methods for medical devices.
• Experience with requirements development, prototyping, risk management, V&V, and design transfer.
• Experience preparing technical documentation for regulatory submissions.
• Strong problem-solving and decision-making skills.
• Experience leading cross-functional programs involving engineering, quality, regulatory, manufacturing, and other functions.
• Hands-on design, prototyping, DFM, process development, and technology transfer.

Responsibilities

• Lead development programs from concept through commercialization, including requirements, risk management, prototyping, testing, and design transfer.
• Provide technical leadership to multidisciplinary engineering and product development teams.
• Lead verification and validation activities across laboratory, preclinical, and clinical-support testing as applicable.
• Develop solutions to complex engineering and product performance challenges.
• Support regulatory activities through preparation and review of technical documentation and engineering reports.
• Lead design reviews, technical decisions, risk mitigation, and product development activities.
• Partner with manufacturing on DFM, process development, technology transfer, and production readiness.
• Manage project priorities, schedules, technical deliverables, resources, and development risks.
• Mentor and provide technical direction to engineers and other technical personnel.

Skills

Regulatory-minded leadership

Experience with medical devices

Cross-functional leadership

Product development oversight

Mechanical design expertise

V&V and design transfer

Prototyping and DFx

Technical problem solving

Education

Bachelor's in Mechanical/Biomedical Engineering or related

Advanced degree preferred

Tools

SolidWorks

Job description

Surf Search Inc. seeks an R&D Manager to lead engineering and product development for new minimally invasive medical devices, guiding projects from concept to commercialization.

The role blends hands-on engineering with strong project leadership and cross-functional collaboration across regulatory, quality, manufacturing, and clinical teams. The ideal candidate has a track record in regulated Class II/III medical devices, strong design, V&V, risk management, and excellent communication.