8+ years mechanical or bio-mechanical engineering experience
Fda quality system regulations 21 cfr part 820 knowledge
Iso 13485 compliance and risk management expertise
Acumed LLC is seeking a Staff Product Development Engineer to lead product development for foot and ankle medical devices from concept to commercialization. The ideal candidate will have extensive experience in mechanical or bio-mechanical engineering, along with strong leadership and technical skills, particularly in the medical device sector
Job Summary
The role drives product development from concept to commercialization while leading at every level within a global industrial organization.
Candidates will mentor engineers, collaborate with department leaders on strategy, and build relationships with surgeons and KOLs.
The position requires ensuring all designs meet FDA/ISO standards and involves organizing cadaver labs with surgical teams.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Staff Product Development Engineer to lead product development for foot and ankle medical devices from concept to commercialization. The ideal candidate will have extensive experience in mechanical or bio-mechanical engineering, along with strong leadership and technical skills, particularly in the medical device sector.
Skills & Requirements
Must-have
8+ years mechanical or bio-mechanical engineering experience
FDA Quality System Regulations 21 CFR Part 820 knowledge
ISO 13485 compliance and risk management expertise
Advanced CAD software and GD&T proficiency
Mentoring engineers and supervising design teams
Nice-to-have
Independent patent analysis skills
Writing technical product papers
Proficiency in multiple technical specialty areas
Serving as independent reviewer for multiple projects
Key Requirements
Bachelor's degree in Mechanical or Bio-Mechanical Engineering
8+ years experience preferred or 14+ years in medical device development
Strong knowledge of surgical anatomy and techniques