Design Quality Engineering Manager-Surgical

4 weeks ago


Austin, Texas, United States Enovis Full time
About Enovis

Enovis Corporation is a leading medical technology company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Our innovative products, services, and integrated technologies fuel active lifestyles in orthopedics and beyond.

Job Summary

We are seeking a highly skilled Design Quality Engineering Manager-Surgical to join our team. As a key member of our Quality Engineering team, you will play a critical role in driving the medical technology industry forward through transforming patient care and creating better patient outcomes.

Key Responsibilities
  • Lead a team of quality engineers responsible for design controls, risk management, V&V strategy, and design transfer for orthopedic implants and instruments
  • Work with the project management office to allocate resources and prioritize business needs
  • Participate in design and manufacturing reviews
  • Generate DFMEAs/UFMEAs and participate in risk analysis discussions
  • Review and approve design and development documentation
  • Serve as subject matter expert for design quality in ISO and FDA audits
  • Author procedures and work instructions that define and govern areas of the quality system
  • Evaluate and disposition nonconforming material
  • Working on complex orthopedic and quality system projects as assigned
  • Has typical authority of a manager including hiring, coaching, and terminating
Requirements
  • Bachelor's in Biomedical or Mechanical Engineering and 5+ years of experience
  • Background in medical devices and knowledge of ISO 13485 and 14971 standards
Preferred Qualifications
  • Supervisory experience desired
  • Knowledge of technical writing quality and best practices


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