Staff Product Development Engineer - Foot & Ankle

Acumed LLC

Addison, Texas, United States
8+ years medical device development experience
Fda/iso design control standards compliance
Advanced testing protocol development and approval
The Staff Product Development Engineer drives product development from concept to commercialization while leading at every level

Job Summary

  • The Staff Product Development Engineer drives product development from concept to commercialization while leading at every level.
  • Candidates will mentor engineers, collaborate with department leaders on strategy, and build relationships with surgeons and KOLs.
  • The role requires ensuring all designs meet FDA/ISO standards and involves organizing cadaver labs with surgical teams.

Matching Summary

The Staff Product Development Engineer drives product development from concept to commercialization while leading at every level.

Skills & Requirements

Must-have

  • 8+ years medical device development experience
  • FDA/ISO design control standards compliance
  • Advanced testing protocol development and approval
  • CAD software and GD&T proficiency
  • Mentoring engineers and designers

Nice-to-have

  • Patent analysis and technical paper writing
  • Independent reviewer for Clinical Data Reports
  • Multiple technical specialty areas expertise
  • ROI analysis for new product opportunities

Key Requirements

  • Bachelor's degree in Mechanical or Bio-Mechanical Engineering
  • 8+ years of relevant engineering experience
  • Knowledge of 21 CFR Part 820 and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter