Design Quality Engineer

About Enovis

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, the company’s extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit

Creating better together. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale.

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.

• Particular focus on supporting sustaining and special instrument teams
• Participating in design and manufacturing reviews
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions
• Reviewing and approving design and development documentation
• Serve as subject‑matter expert for design quality in ISO and FDA audits
• Authoring procedures and work instructions that define and govern the quality system
• Conduct internal audits of the quality system and other business functions
• Evaluating nonconforming material and dispositioning based on cross‑functional engineering review
• Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
• Reviewing trends in device failures associated with customer complaints and nonconforming material
• Leading and owning corrective and preventive actions
• Working on complex special projects as assigned

• Bachelor’s in Biomedical or Mechanical Engineering and 3+ years of experience
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO
  13485 quality standards
• Knowledge of technical writing quality and best practices
• Required basic knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, and sterilization
• Knowledge of Microsoft Office Suite or equivalent software

Up to 10%.

• Preferred knowledge of software packages such as Solidworks, Solidworks ePDM, Oracle R12, Agile PLM
• CQE, Lean, or 6 Sigma certification
• Advanced knowledge of ISO 14971 and risk management principles
• Detail oriented and analytical

Ability to sit/stand for long periods of time.

• Advanced proficiency in Microsoft applications, particularly Excel and Word
• Working knowledge of U.S. and international quality system regulations
• Strong interpersonal communication and teamwork skills
• Excellent organizational, prioritization, and communication skills (written and verbal)
• Fluent in English; additional proficiency in Spanish, German, and/or French is a plus
• Life sciences quality/regulatory industry experience desired (medical devices, pharmaceutical, or biotech)

General office setting that is clean, orderly, properly lit, and ventilated. Noise levels are considered low to moderate.

Enovis provides equal employment opportunities based on merit, experience, and other work‑related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law.