Staff Product Development Engineer - Foot & Ankle

Acumed LLC

Addison, TX, United States
Fda/iso design control standards
Risk management
Verification/validation
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

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.
  • We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.
  • 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

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.

Skills & Requirements

Must-have

  • FDA/ISO design control standards
  • risk management
  • verification/validation
  • CAD/PLM and ERP systems
  • GD&T
  • ECO/ECR
  • SAP

Nice-to-have

  • independent patent analysis
  • writing technical product papers
  • multiple technical specialty areas
  • independent reviewer for multiple projects

Key Requirements

  • Bachelor’s degree in Mechanical or Bio-Mechanical Engineering
  • 8+ years’ experience preferred
  • 14+ years in medical device development
  • Ability to mentor/supervise engineers
  • lead large, complex projects
  • proficiency with 3D/2D CAD software
  • Geometric Dimensioning & Tolerancing (GD&T)
  • tolerance stack analysis
  • FDA Quality System Regulations (21 CFR Part 820)
  • ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter