Staff Product Development Engineer - Foot & Ankle

Acumed LLC

Addison, TX, United States
On-site
Product development from concept to commercialization
Fda/iso design control standards
Risk management, verification/validation
Acumed LLC is seeking a Staff Product Development Engineer for their Addison, TX location, focusing on driving product development in the Foot & Ankle division. The role requires extensive experience in medical device development, leadership capabilities, and technical expertise, particularly in mechanical or bio-mechanical engineering

Job Summary

  • The Staff Product Development Engineer drives product development from concept to commercialization, including research, planning, concept creation, specifications, testing, validation, and communication with teams, management, and customers.
  • This role involves mentoring and supervising engineers, collaborating with department leaders on strategy, and building relationships with external design resources, KOLs, and surgeons.
  • Ensure product designs and documentation meet FDA/ISO design control standards, including risk management, verification/validation, and proper use of CAD/PLM and ERP systems.

Matching Summary

Match Score: 85

Acumed LLC is seeking a Staff Product Development Engineer for their Addison, TX location, focusing on driving product development in the Foot & Ankle division. The role requires extensive experience in medical device development, leadership capabilities, and technical expertise, particularly in mechanical or bio-mechanical engineering.

Skills & Requirements

Must-have

  • product development from concept to commercialization
  • FDA/ISO design control standards
  • risk management, verification/validation
  • CAD/PLM and ERP systems
  • Geometric Dimensioning & Tolerancing (GD&T)

Nice-to-have

  • independent patent analysis
  • writing technical product papers
  • proficiency in multiple technical specialty areas

Key Requirements

  • Bachelor's degree in Mechanical or Bio-Mechanical Engineering with 8+ years' experience
  • 14+ years in medical device development
  • Ability to mentor/supervise engineers
  • Lead large, complex projects
  • Strong knowledge of surgical anatomy, techniques, and products
  • Familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter