{"id":2891824,"url":"https://alion.io/job/smithnephew-design-quality-engineer","title":"Design Quality Engineer","company":{"id":1768800,"name":"Smith+Nephew","domain":"smith-nephew.com","url":"https://alion.io/company/smith-nephew-com","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":78,"open_postings":62,"ghost_share":0,"stale_share":0.871,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-28T05:59:10Z"}},"role":"MedTech","role_family":"MedTech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Mansfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":74250,"max":111500,"currency":"USD","period":"year","gross":null,"usd_annual":111500},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-19T00:00:00Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-28T21:06:11Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.\nAre you passionate about quality, innovation, and patient safety? Do you enjoy working across functions to ensure medical devices remain safe, effective, and compliant throughout their lifecycle?\nJoin Smith+Nephew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world.\nAs a Design Quality Engineer, you will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.\nBefore applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization\nWhat will you be doing?\nSupport product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.\nLead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.\nReview and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.\nInvestigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.\nEnsure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.\nCollaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.\nProvide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.\nDrive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.\n\nWhat will you need to be successful?\nRequired Qualifications\nBachelor of Science degree in Engineering or a related technical discipline.\n Minimum of 2 years of experience in the medical device industry or another regulated environment.\nWorking knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes\nStrong analytical, communication, collaboration, and problem-solving skills.\nAbility to develop and implement solutions to complex quality challenges.\nPreferred Qualifications\nCertified Quality Engineer (CQE).\nSix Sigma certification.\nExperience supporting sustaining engineering and product lifecycle management.\nExperience participating in audits, inspections, and regulatory submissions.\nPhysical Demands\nPrimarily seated work with occasional light lifting.\nTravel Requirements\nLess than 10% travel.\nYou Unlimited.\nWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.\n Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).\nYour Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement \nWork/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day \n Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program \nTraining: Hands-On, Team-Customized, Mentorship \n Extra Perks: Discounts on fitness clubs, travel and more! \nThe anticipated base compensation range for this position is $74,250 to $111,500 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.\nIn addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.\nSmith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.\nStay connected by joining our Talent Community.\nWe'remore than just a company - we'rea community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.\nCheck us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.\nExplore our website and learn more about our mission, our team, and the opportunities we offer.","description_format":"text","description_chars":5264,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Parental leave","Stock options"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-10-20T02:55:24Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 33 · green card filings: 11","filings_12m":33,"filings_prev_12m":52,"green_card_filings_12m":11,"median_offered_wage_usd":121250,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":9,"expected_fill_days":33,"reasons":["conf:2","stale_co","velocity","win:early","comp:junior,brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":111500,"is_top_pay":false},"html_url":"https://alion.io/job/smithnephew-design-quality-engineer","json_url":"https://alion.io/job/smithnephew-design-quality-engineer.json","meta":{"generated_at":"2026-10-29T00:01:38Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":33,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1768800},"rest":"https://alion.io/mcp/rest/get_company?id=1768800"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsmithnephew-design-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsmithnephew-design-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsmithnephew-design-quality-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/smithnephew-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmithnephew-design-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2891824}},{"tool":"search_jobs","arguments":{"company":"smith-nephew.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2891824},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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