Staff Product Development Engineer - Foot & Ankle

Acumed LLC

Addison, TX, United States
Not specified
8+ years medical device development experience
Fda/iso design control standards compliance
Mentoring engineers and designers
Acumed LLC is seeking a Staff Product Development Engineer for their Addison, TX location, primarily focused on driving product development in the medical device sector, particularly in foot and ankle solutions. The ideal candidate will have extensive experience in product development, leadership capabilities, and strong technical expertise in engineering and regulatory standards

Job Summary

  • The role drives product development from concept to commercialization within the global industrial organization Marmon Holdings.
  • Candidates will mentor engineers, collaborate on corporate strategy, and build relationships with surgeons and KOLs.
  • The position requires ensuring all designs meet FDA/ISO standards while utilizing CAD/PLM and ERP systems.

Matching Summary

Match Score: 85

Acumed LLC is seeking a Staff Product Development Engineer for their Addison, TX location, primarily focused on driving product development in the medical device sector, particularly in foot and ankle solutions. The ideal candidate will have extensive experience in product development, leadership capabilities, and strong technical expertise in engineering and regulatory standards.

Skills & Requirements

Must-have

  • 8+ years medical device development experience
  • FDA/ISO design control standards compliance
  • Mentoring engineers and designers
  • Advanced testing protocols and validation
  • Surgical anatomy and techniques knowledge

Nice-to-have

  • Independent patent analysis skills
  • Writing technical product papers
  • Proficiency in multiple technical specialty areas
  • Cadaver lab organization experience
  • 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

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