Medical Device Design Quality Engineer

Enovis Corporation

Austin, TX, USA
Design and manufacturing reviews
Dfmeas/ufmeas and risk analysis
Design and development documentation review
As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes

Job Summary

  • As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
  • Utilizing a comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.
  • This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.

Matching Summary

As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Skills & Requirements

Must-have

  • Design and manufacturing reviews
  • DFMEAs/UFMEAs and risk analysis
  • Design and development documentation review
  • ISO and FDA audit SME
  • Quality system procedures authoring
  • Nonconforming material evaluation
  • Compliance to specifications and standards

Nice-to-have

  • Detail oriented and analytical
  • Collaboration with partners and patients
  • Continuous improvement culture
  • Transforming medical technology

Key Requirements

  • Bachelor's in Biomedical or Mechanical Engineering
  • 3+ years of experience
  • 1 year in design focused environment
  • Background in regulated industry
  • Knowledge of manufacturing processes
  • Knowledge of Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

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