Design Quality Engineer - Medical Devices

Encore Medical LP; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Enovis seeks a Quality Assurance Engineer – Design Quality Focus in Austin, TX. The role supports New Product Development and Sustaining Product Development, serving as the QA representative on PD initiatives.

The candidate will review design documentation, author quality procedures, and lead audits to ensure GMP/ISO compliance, while collaborating with cross-functional teams to drive quality improvements.

Qualifications

• Bachelor’s in Biomedical or Mechanical Engineering; 3+ years of experience, with at least 1 year in a design-focused environment.
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; ISO13485 knowledge preferred.
• Knowledge of technical writing quality and best practices.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, and sterilization.
• Proficiency with Microsoft Office Suite.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Reviewing and approving design and development documentation.
• Serving as subject matter expert for design quality in ISO and FDA audits.
• Authoring procedures and work instructions that define and govern the quality system.
• Conducting internal audits of the quality system and other business functions.
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review.
• Ensuring compliance to GMP, ISO, FDA, and MDD standards.
• Reviewing trends in device failures and customer complaints.
• Leading corrective and preventive actions.
• Participating in Health Hazard Evaluations.
• Working on complex special projects as assigned.

Skills

Detail oriented

Analytical

Microsoft Office proficiency

Education

Bachelor’s in Biomedical or Mechanical Engineering

Tools

Solidworks

Solidworks ePDM

Oracle R12

Agile PLM

Job description

Enovis seeks a Quality Assurance Engineer – Design Quality Focus in Austin, TX. The role supports New Product Development and Sustaining Product Development, serving as the QA representative on PD initiatives.

The candidate will review design documentation, author quality procedures, and lead audits to ensure GMP/ISO compliance, while collaborating with cross-functional teams to drive quality improvements.