Medical Device Design Quality Engineer

About the role

Enovis is seeking a Design Quality Engineer to join its Quality Assurance team in Austin, TX. The role supports new and sustaining product development, ensuring compliance with regulatory and company standards while driving continuous improvement.

Key responsibilities

• Participate in design and manufacturing reviews, generate DFMEAs/UFMEAs, and engage in risk analysis discussions.
• Review and approve design and development documentation and serve as the subject‑matter expert for ISO and FDA audits.
• Author procedures and work instructions, conduct internal audits, and evaluate non‑conforming material.
• Lead corrective and preventive actions, review device failure trends, and work on special projects.

Required profile

• Bachelor’s degree in Biomedical or Mechanical Engineering with at least 3 years of experience, including 1 year in a design‑focused environment.
• Background in a highly regulated industry such as medical devices, aeronautics, or automotive.
• Knowledge of manufacturing processes like metrology, precision machining, grinding, cleaning, and sterilization.
• Ability to travel up to 10% and lift/carry up to 25 lbs.

Required skills

• SolidWorks and SolidWorks ePDM.
• Oracle R12 and Agile PLM.
• Familiarity with ISO 13485, ISO 14971, GMP, FDA, and MDD requirements.
• Proficiency with Microsoft Office Suite.