Medical Device Design Quality Engineer

About the role

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. 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. Reports to Design Quality Engineering Manager. Location: Austin, TX. Business Unit: US Surgical. Travel up to 10% may be required.

Responsibilities

• 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
• Participating in Health Hazard Evaluations
• Working on complex special projects as assigned

Requirements

• Bachelor’s in Biomedical or Mechanical Engineering and 3+ years of experience, with at least 1 year in design focused environment (or equivalent combination of education and years of experience)
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required
• Knowledge of technical writing quality and best practices
• Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization
• Individual should have knowledge of Microsoft Office Suite of software or equivalent
• Ability to sit/stand for long periods of time
• Ability to lift/carry/pull up to 25 lbs

Skills

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