{"id":3014919,"url":"https://alion.io/job/smithnephew-design-quality-engineer-2","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":77,"open_postings":66,"ghost_share":0,"stale_share":0.924,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-10-24T06:02:35Z"}},"role":"MedTech","role_family":"MedTech","seniority":"junior","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":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"Sterilization Validation","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-21T16:22:02Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-22T06:32:22Z","board_verified":false,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.\nJoin our ENT New Product Development team as a Design Quality Engineer in Austin WC, where you will help bring safe, reliable medical device technologies from concept through development. This is an opportunity to build your quality engineering expertise while partnering across functions and helping ensure new products meet rigorous quality and regulatory requirements.\nWhat will you be doing?\nSupport design controls and quality activities, including design verification and validation, sterilization validation, process validation, supplier qualification, test methods, capability studies and risk management documentation.\nDevelop methods and procedures that help ensure products meet required specifications and standards, with product safety and reliability established through appropriate testing.\nSupport manufacturing operations with expertise in product requirements, risk management, test methods and statistical analysis.\nHelp ensure compliance with applicable quality and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.\nPartner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.\nSupport continuous improvement activities, including CAPA, nonconformance and internal audit activities.\nContribute to Post Market Surveillance, Management Review and audit and inspection activities.\nWhat will you need to be successfu l?\nBachelor’s degree in Engineering.\n0 to 2 years of experience in the medical device or a related industry, with a general or basic understanding of Design Control and requirements such as FDA CFR 820, ISO 13485, EU MDR and GxP.\nAbility to manage and prioritize multiple projects, tasks and deadlines while working effectively as part of a team.\nEffective written and verbal communication skills, with proficiency in Excel and AI tools.\nA statistical background is preferred.\nAbility to travel less than 5%\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":3588,"description_truncated":false,"requirements":{"experience_years_min":null,"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":"2026-10-21T16:22:02Z"}],"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":2,"expected_fill_days":31,"reasons":["conf:47","stale_co","velocity","win:early","comp:junior,brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/smithnephew-design-quality-engineer-2","json_url":"https://alion.io/job/smithnephew-design-quality-engineer-2.json","meta":{"generated_at":"2026-10-25T00:14:22Z","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":332,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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-2"},{"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-2"},{"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-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\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmithnephew-design-quality-engineer-2"}]}