{"id":1271553,"url":"https://alion.io/job/smithnephew-netherlands-sustaining-design-quality-engineering-manager","title":"Sustaining Design Quality Engineering Manager","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":79,"open_postings":67,"ghost_share":0,"stale_share":0.836,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Leadership","role_family":"Leadership","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mansfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96750,"max":145000,"currency":"USD","period":"year","gross":null,"usd_annual":145000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-17T00:00:00Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-31T03:20:55Z","board_verified":true,"closed_at":null,"days_open":44,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":44},"description":"Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.\nAre you a quality leader passionate about driving excellence across the full product lifecycle? This is an opportunity to lead a high performing engineering team, influence strategic initiatives, and ensure life enhancing medical technologies remain safe, effective, and compliant. Based in Mansfield, MA, you will play a critical role in sustaining innovation while shaping quality practices across the organization.\nWhat will you be doing?\nLeading a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle\nDriving product lifecycle management initiatives and strategically allocating resources to meet business needs\nEnsuring robust and compliant design control practices, maintaining Design History File integrity\nReviewing and approving key quality deliverables including verification and validation, risk management, CAPAs, and design changes\nPartnering with cross functional teams to ensure products meet safety, performance, and regulatory requirements\nSupporting regulatory submissions and representing design control activities during audits\nLeading DHF assessments and conducting gap analyses to drive compliance and continuous improvement\nProviding technical leadership and mentorship to develop quality engineering talent\nInfluencing stakeholders and resolving complex quality, technical, and operational challenges.\nWhat will you need to be successful?\nBachelor of Science in Engineering or a related technical field\n5+ years of experience in the medical device industry or a similarly regulated environment\nStrong knowledge of FDA QSR, ISO 13485, and ISO 14971\nProven leadership experience managing and developing engineering teams\nAbility to collaborate cross functionally and communicate effectively at all levels\nExperience driving design control activities and solving complex quality challenges\nCQE or Lead Auditor certification preferred\nThe anticipated base compensation range for this position is $96,750.00 to $145,000.00 USD annually.\nThe actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.\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.\nYou. Unlimited.\nWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. \nInclusion 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 Purchase Plan, Tuition Reimbursement \nWork/Life Balance: Flexible Personal Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day \nYour Wellbeing: Medical, Dental, Vision, Health Savings Account Employer Contribution of $500+ annually, Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program \nFlexibility: Hybrid Work Model for most professional roles \nTraining: Hands On, Team Customized, Mentorship \nExtra Perks: Discounts on fitness clubs, travel and more\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":4263,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Hybrid work","Parental leave"],"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":"2026-10-14T02:00:51Z"}],"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":"2026-10-29T16:27:21+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":23,"band":"cold","label":"Long shot","p_open":1,"p_active":0.519,"p_room":0.44,"age_days":44,"expected_fill_days":31,"reasons":["conf:2","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":145000,"is_top_pay":false},"html_url":"https://alion.io/job/smithnephew-netherlands-sustaining-design-quality-engineering-manager","json_url":"https://alion.io/job/smithnephew-netherlands-sustaining-design-quality-engineering-manager.json","meta":{"generated_at":"2026-10-31T06:15:26Z","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":9142,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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-netherlands-sustaining-design-quality-engineering-manager"},{"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-netherlands-sustaining-design-quality-engineering-manager"},{"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-netherlands-sustaining-design-quality-engineering-manager"},{"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-netherlands-sustaining-design-quality-engineering-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmithnephew-netherlands-sustaining-design-quality-engineering-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1271553}},{"tool":"search_jobs","arguments":{"company":"smith-nephew.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1271553},"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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