R&D Manager - Minimally Invasive Medical Devices

Surf Search Inc.; Carlsbad (CA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Surf Search Inc. is seeking an R&D Manager to lead engineering and product development for new minimally invasive medical devices. The role covers from concept and technical definition through verification, validation, transfer and commercialization.

This position requires hands-on engineering, project leadership, and team management across engineering, quality, regulatory, manufacturing, clinical, and commercial functions.

Qualifikationen

• Bachelor's degree in Mechanical or Biomedical Engineering (advanced degree preferred).
• 7+ years of experience developing regulated Class II/III medical devices.
• 3+ years of experience leading engineers/technical personnel.
• Experience developing catheter-based or minimally invasive devices.
• Strong understanding of mechanical design, materials and manufacturing for medical devices.
• Experience with requirements, prototyping, risk management, V&V and design transfer.
• Experience preparing documentation for regulatory submissions.

Aufgaben

• Lead development programs from concept through commercialization, including requirements and design transfer.
• Provide technical leadership to multidisciplinary teams.
• Lead verification and validation activities (lab, preclinical, clinical support).
• Develop solutions to complex engineering and product performance challenges.
• Support regulatory activities with technical docs and reports.
• Lead design reviews, risk mitigation and product development activities.
• Partner with manufacturing on DFM, process development and technology transfer.
• Manage project priorities, schedules, deliverables, resources and risks.
• Mentor and provide direction to engineers.

Kenntnisse

Cross-functional leadership

Project leadership

Technical problem-solving

Communication skills

Ausbildung

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Jobbeschreibung

Surf Search Inc. is seeking an R&D Manager to lead engineering and product development for new minimally invasive medical devices. The role covers from concept and technical definition through verification, validation, transfer and commercialization.

This position requires hands-on engineering, project leadership, and team management across engineering, quality, regulatory, manufacturing, clinical, and commercial functions.