{"id":1907651,"url":"https://alion.io/job/enovis-medical-device-design-quality-engineer","title":"Medical Device Design Quality Engineer","company":{"id":5048,"name":"Enovis","domain":"enovis.com","url":"https://alion.io/company/enovis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":20,"ghost_share":0,"stale_share":0.65,"repost_share":0,"time_to_fill_p50_days":24,"computed_at":"2026-11-04T06:34:25Z"}},"role":"MedTech","role_family":"MedTech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":66000,"max_usd":127000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":43},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Oracle ERP","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-10-05T13:19:23Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-11-05T00:25:23Z","board_verified":true,"closed_at":null,"days_open":30,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":30},"description":"Who We Are\nABOUT ENOVIS™\nEnovis 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 www.enovis.com.\nWhat You'll Do\nAt Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.\nBecause that’s how we change the lives of patients for the better. And that’s how we create better together.\nAs 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.\nJob Title:\nQuality Assurance Engineer - Design Quality Focus\nReports To:\nDesign Quality Engineering Manager\nLocation:\nAustin, TX\nBusiness Unit Description:\nUS Surgical\nJob Title/High Level Position Summary:\nUtilizing 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.\nThis position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.\nKey Responsibilities:\nParticipating in design and manufacturing reviews\nGenerating DFMEAs/UFMEAs and participating in risk analysis discussions\nReviewing and approving design and development documentation\nServe as subject matter expert for design quality in ISO and FDA audits\nAuthoring procedures and work instructions that define and govern the quality system\nConduct internal audits of the quality system and other business functions\nEvaluating nonconforming material and dispositioning based on cross-functional engineering review\nAssuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)\nReviewing trends in device failures associated with customer complaints and nonconforming material\nLeading and owning corrective and preventive actions\nParticipating in Health Hazard Evaluations\nWorking on complex special projects as assigned\nMinimum Basic Qualifications:\nBachelor’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).\nBackground in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 quality standards.\nKnowledge of technical writing quality and best practices.\nRequired basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization.\nIndividual should have knowledge of Microsoft Office Suite of software or equivalent.\nTravel Requirements:\nUp to 10%\nDesired Characteristics:\nPreferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.\nPrefer CQE, Lean, or 6 Sigma Certification.\nAdvanced knowledge of ISO 14971 and risk management principles\nDetail oriented and analytical\nPhysical Requirements:\nAbility to sit/stand for long periods of time\nAbility to lift/carry/pull up to 25 lbs\nEQUAL EMPLOYMENT OPPORTUNITY\nEnovis 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. 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