R&D Engineer

Job Title:

R&D Engineer (Medical Devices)

Location:

United States Duration: 12 Months Contract

Job Summary:

We are seeking an R&D Engineer with experience in the medical device industry to support product design, development, and innovation initiatives. This role will focus on developing new products, improving existing designs, and ensuring compliance with regulatory standards. The ideal candidate will have strong engineering fundamentals, hands‑on product development experience, and the ability to work in a cross‑functional, fast‑paced environment.

• Design and develop new medical device products from concept to commercialization
• Support product development activities including prototyping, testing, and design verification/validation
• Create and maintain design documentation (requirements, specifications, drawings, reports)
• Perform risk assessments (FMEA) and support design controls per regulatory requirements
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory, and Suppliers
• Conduct root cause analysis and support product improvements and issue resolution
• Ensure compliance with FDA regulations and ISO 13485 standards
• Support design transfer activities to manufacturing

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or related field
• 3–7+ years of experience in R&D or product development within the medical device industry
• Hands‑on experience with product design, prototyping, and testing
• Knowledge of design controls and regulatory requirements (FDA, ISO 13485)
• Experience with risk management tools (FMEA, DFMEA, PFMEA)

• Experience with CAD tools (Solid Works, Creo, or similar)
• Experience with materials, plastics, or electromechanical systems
• Knowledge of ISO 14971 (risk management)
• Experience in a regulated GMP environment