Senior Product Development Engineer

Senior Product Development Engineer

Medical Device Industry | Full-Time | Onsite/Hybrid (Mahwah, New Jersey)

$/yr - $/yr

We are an innovative medical device company developing mechanical and disposable products used in regulated healthcare environments. We’re seeking a Senior Product Development Engineer who can own complex projects, mentor others, and lead products from early concept through commercial production.

This role is ideal for an engineer who thrives in hands‑on development, understands manufacturing realities, and can balance technical rigor with practical execution.

• Lead the design, development, and testing of disposable and mechanical medical devices
• Provide technical ownership from concept through production
  , including design controls and manufacturing transfer
• Apply DFM/DFA principles to ensure designs are manufacturable, scalable, and cost‑effective
• Utilize pilot production methods
  , DOE, and FMEA to establish proof of concept and reduce risk
• Develop detailed Solid Works designs
  , specifications, and tolerance analyses aligned with vendor capabilities
• Lead prototype builds, verification, and validation testing efforts
• Support regulatory submissions and product transfers within FDA and ISO 13485 frameworks
• Partner with Quality, Manufacturing, Supply Chain, and external vendors to resolve technical challenges
• Support existing products through quality improvements, cost reduction, and supply continuity initiatives

• BS in Mechanical, Biomedical, or related Engineering (MS a plus)
• 5+ years of experience in medical device product development
• Strong proficiency in Solid Works or similar CAD tools
• Proven experience taking products from concept to commercialization
• Deep understanding of DFM/DFA, tolerancing, and manufacturing processes
• Experience with DOE, FMEA, and pilot builds
• Working knowledge of FDA design controls, validation, and ISO 13485
• Strong technical judgment, problem‑solving ability, and project ownership mindset

• Experience with plastics, injection molding, and disposable medical devices
• Exposure to sterilization methods and their impact on materials and packaging
• Experience supporting manufacturing process validation (IQ/OQ/PQ)
• Informal or formal mentorship of junior engineers

• High‑impact ownership of products that reach real patients
• Opportunity to influence technical direction and best practices
• Work across the full product lifecycle—not siloed design work

Mid‑Senior level

Full‑time

Engineering, Research, and Design

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Aviation and Aerospace Component Manufacturing