Not specified (assumed to be onsite based on location)
8+ years medical device experience
Fda/iso design control standards
Cadaver lab organization with surgeons
Acumed LLC is seeking a Staff Product Development Engineer to lead product development from concept to commercialization, with responsibilities including mentoring engineers, collaborating with cross-functional teams, and ensuring compliance with FDA/ISO standards. The ideal candidate should possess a degree in Mechanical or Bio-Mechanical Engineering, extensive experience in medical device development, and strong leadership and technical skills
Job Summary
The Staff Product Development Engineer drives product development from concept to commercialization while mentoring and supervising engineering teams.
Candidates must ensure all product designs and documentation strictly meet FDA/ISO design control standards including risk management and verification.
This role involves building relationships with external design resources, KOLs, and surgeons to guide business development and R&D strategies.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Staff Product Development Engineer to lead product development from concept to commercialization, with responsibilities including mentoring engineers, collaborating with cross-functional teams, and ensuring compliance with FDA/ISO standards. The ideal candidate should possess a degree in Mechanical or Bio-Mechanical Engineering, extensive experience in medical device development, and strong leadership and technical skills.
Skills & Requirements
Must-have
8+ years medical device experience
FDA/ISO design control standards
Cadaver lab organization with surgeons
Advanced testing protocol development
Mentoring engineers and designers
Nice-to-have
Independent patent analysis skills
Writing technical product papers
Multiple technical specialty areas
Surgical anatomy expertise
Market insight for business development
Key Requirements
Bachelor's degree in Mechanical or Bio-Mechanical Engineering