New Product Development Engineer

About the Role: We are seeking an innovative New Product Development (NPD) Engineer to drive the design and commercialization of next-generation medical devices. In this role, you will take concepts from early-stage feasibility through design transfer, ensuring compliance with rigorous regulatory standards. If you have a passion for solving complex engineering challenges and improving patient outcomes, we want to connect with you.Key Responsibilities:Lead and support full-lifecycle product development, from concept generation and prototyping to design verification and manufacturing transfer.Create and maintain detailed 3D CAD models, engineering drawings, and precise GD&T specifications (SolidWorks/Creo).Compile and manage Design History File (DHF) documentation in accordance with FDA 21 CFR Part 820 and ISO 13485.Facilitate risk management activities, including the development of Use and Design FMEAs per ISO 14971.Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to ensure seamless product launches.Qualifications:B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or a related field.3-20 years of progressive experience in medical device product development (open to highly experienced candidates up to 20+ years looking for technical leadership roles).Strong proficiency in 3D CAD software (SolidWorks preferred) and tolerance stack-up analysis.Demonstrated experience with Design Controls, DHF creation, and phase-gate development processes.Hands-on experience with rapid prototyping, fixture design, and material selection.