Hiring: Design Quality Engineer Company: Enovis Location: Austin, TX Job Posted Time: 2026-09-03 10:29:39 Target Skills & Keywords : Agile, Lit About the job Experience: •3+ years of experience. Required Skills: •This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives. •The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet business needs. •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 Qualifications: •To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. •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 ISO13485 quality standards. •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. •Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM. •CQE, Lean, or 6 Sigma Certification. •Advanced knowledge of ISO 14971 and risk management principles •Demonstrated capacity to sit/stand for long periods of time Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!