R&D Manager

The R&D Manager will lead engineering and product development activities for new minimally invasive medical devices while supporting improvements to existing products. This position will oversee projects from early concept and technical definition through verification, validation, transfer, and commercialization.

The role combines hands-on engineering, technical problem-solving, project leadership, and team management. The ideal candidate has experience developing complex regulated medical devices and can work effectively across engineering, quality, regulatory, manufacturing, clinical, and commercial functions.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline; advanced degree preferred.
• 7+ years of experience developing regulated Class II and/or Class III medical devices through the full product lifecycle.
• 3+ years of experience managing or leading engineers and technical personnel.
• Experience developing catheter-based, minimally invasive, or other small-scale disposable medical devices.
• Strong understanding of mechanical design, materials, components, and manufacturing methods used in medical devices.
• Demonstrated experience with requirements development, prototyping, risk management, V&V, and design transfer.
• Experience preparing technical documentation supporting regulatory submissions and product development.
• Strong technical problem-solving skills and demonstrated ability to make sound engineering decisions.
• Experience leading cross-functional development programs involving engineering, quality, regulatory, manufacturing, and other functions.
• Hands-on experience with product design, prototyping, DFM, process development, and technology transfer.
• Experience with Solid Works or comparable CAD software.
• Strong written, verbal, and interpersonal communication skills.
• Ability to work independently while providing technical and organizational leadership to a collaborative team.

• 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, including 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.

Occupational Code: 11-9121.00 - Natural Sciences R&D Managers