Sr. R&D Engineer, Products

Department: Research & Development

Location: US-North Carolina-Raleigh

We are seeking a Sr. R&D Engineer, New Products to lead the research, design, development, and launch of innovative medical devices from concept through commercialization. This role partners closely with cross‑functional teams across R&D, Product Management, Clinical, Quality, Regulatory, and Operations to identify unmet needs, evaluate new technologies, develop and test prototypes, and translate insights into robust product solutions. The engineer thrives in fast‑paced product development environments and enjoys solving complex technical challenges from early feasibility through product launch and post‑launch improvement.

• Lead product development work streams from concept through launch, including planning, execution, and cross‑functional coordination.
• Design, prototype, and evaluate product concepts using biomechanical models, benchtop methods, and experimental testing.
• Develop and execute verification and validation activities to assess product performance and design robustness.
• Design, build, and verify test hardware, fixtures, and systems, including automation tools, as needed to support product development.
• Apply sound mechanical and engineering principles to understand, model, and solve problems involving complex systems.
• Perform statistical analysis and interpret data to guide technical decisions and product improvements.
• Communicate technical findings, recommendations, and product insights effectively to stakeholders at all levels.
• Collaborate with cross‑functional partners to incorporate design inputs, technical requirements, and user needs into product prototypes and final designs.
• Partner with Clinical Affairs and cross‑functional teams to support clinical studies and other product investigations.
• Generate clear, complete technical documentation in compliance with FDA, ISO, and internal medical device development requirements, including protocols, reports, and design documentation.
• Contribute to invention generation, intellectual property development, and patent disclosures.
• Prioritize and execute work effectively in a fast‑paced environment with evolving priorities and critical timelines.
• Provide broad engineering support as needed.

• B.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 8+ years of experience in biomedical research and/or product development.
• M.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 6+ years of experience in biomedical research and/or product development.
• Ph.D. in Mechanical Engineering, Biomedical Engineering, or a related field with 3+ years of experience in biomedical research and/or product development.
• Higher or lower years of experience will be considered for this role, with job level and title adjusted accordingly.
• Strong theoretical and experimental background in structural mechanics and biomechanics.
• Experience with 3D CAD solid modeling and mesh‑based modeling tools.
• Test method development, verification, and validation.
• Data analysis, scripting, and automation for experimental and design workflows.
• Additive manufacturing (3D printing) for test fixtures, prototypes, and end‑use product applications.
• Experience in the medical device industry.

• Medical, dental, and vision coverage for employees and eligible dependents.
• Health Savings Account option for certain medical plans.
• Employee discount on Invisalign and Vivera after 90 days of employment.
• Back‑up child/elder care and caregiving concierge access.
• Family forming benefits for employees and their spouse or domestic partner.
• Breast milk delivery and lactation support services.
• Employee assistance program.
• Hinge Health virtual physical therapy for eligible employees and dependents (age 18+).
• Short‑term and long‑term disability insurance.
• Basic life insurance and accidental death and dismemberment; voluntary supplemental life options.
• Flexible spending accounts for health care, dependent care, and commuter benefits.
• 401(k) plan with company match and Roth and after‑tax options.
• Employee stock purchase program.
• Paid vacation up to 17 days in the first year,…