{"id":4103614,"url":"https://alion.io/job/smithnephew-design-quality-engineer-2-2","title":"Design Quality Engineer 2","company":{"id":1768800,"name":"Smith+Nephew","domain":"smith-nephew.com","url":"https://alion.io/company/smith-nephew-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":90,"ghost_share":0,"stale_share":0.678,"repost_share":0.078,"time_to_fill_p50_days":31,"computed_at":"2026-11-11T05:49:22Z"}},"role":"MedTech","role_family":"MedTech","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","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":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"Sterilization Validation","optional":false},{"name":"Verification & Validation","optional":true}],"status":"live","first_seen_at":"2026-11-11T22:11:37Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-12T04:42:02Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.\nJoin our Quality team in Austin and help bring safe, reliable medical device innovations to life. As a Quality Engineer, you will be a key quality partner for new product development, working across functions to ensure products meet demanding quality, safety, performance and regulatory requirements.\nWhat will you be doing?\n\nProvide quality leadership for new product development project teams, serving as the Quality Engineering representative and partnering with cross functional teams.\nGenerate, approve and manage design verification, design validation, sterilization validation, process validation, supplier qualification and test method activities.\nDevelop protocols, capability studies and risk assessments to support product safety, reliability and overall risk management.\nEnsure compliance with applicable product standards and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN and EU MDR requirements.\nSupport manufacturing operations with expertise in product requirements, inspection and test methods, root cause investigations and issue resolution.\nPartner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.\nSupport continuous improvement and compliance activities, including CAPA resolution and nonconformance investigations.\nSupport Post Market Surveillance, Quality Management Reviews and internal and external audits or inspections.\nWhat will you need to be successful?\n\nA 4-year technical degree is required, a bachelor's degree in biomedical or mechanical engineering is highly preferred\n2-5 years in the medical device industry\nFamiliarity with process development and new product development is a plus.\nExperience with design verification and validation, process or sterilization validation, risk management, test methods, supplier qualification and investigation or CAPA activities.\nWorking knowledge of relevant medical device regulations and standards, including US FDA, QSR, cGMP, ISO and EU MDR requirements\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. \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 \n Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program \n Flexibility: 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":3659,"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","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":"2026-11-11T22:11:37Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"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":"2026-11-11T07:38:50+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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":31,"reasons":["conf:0","win:early","comp:brand"],"computed_at":"2026-11-12T05:02:49Z"},"pay":null,"html_url":"https://alion.io/job/smithnephew-design-quality-engineer-2-2","json_url":"https://alion.io/job/smithnephew-design-quality-engineer-2-2.json","meta":{"generated_at":"2026-11-12T05:02:49Z","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":11046,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-2-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-2-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-2-2"},{"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-2-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmithnephew-design-quality-engineer-2-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4103614}},{"tool":"search_jobs","arguments":{"company":"smith-nephew.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4103614},"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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