{"id":1091818,"url":"https://alion.io/job/medtronic-sr-design-quality-engineer-2","title":"Sr. Design Quality Engineer","company":{"id":638,"name":"Medtronic","domain":"medtronic.com","url":"https://alion.io/company/medtronic","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":183,"ghost_share":0.044,"stale_share":0.301,"repost_share":0.191,"time_to_fill_p50_days":19,"computed_at":"2026-11-11T05:49:22Z"}},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Memphis, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":147600,"currency":"USD","period":"year","gross":null,"usd_annual":147600},"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 of Experiments","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-09-21T14:41:32Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-11-11T04:35:05Z","board_verified":true,"closed_at":null,"days_open":50,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":50},"description":"We anticipate the application window for this opening will close on - 25 Nov 2026Position Description:\nDevelop and evaluate designs which meet defined medical device product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project mgmt. and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) & Design for Reliability and Manufacturability (DRM), MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including medical device materials and related processes. Utilize design development, analysis and statistical tools including Minitab, and statistical methods including DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R (Reliability and Repeatability), ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis. Evaluate products and process risks using Failure Mode Effects Analysis (FMEA), utilizing ISO14971. Conduct QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) identification and leverage knowledge of FDA 21 CFR part 820, ISO 13485 and Good Documentation Practices (GDP). Utilize Lean sigma, including design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone). Execute Process Qualification including IQ (Installation Qualification), OQ (operation Qualification) and PQ (Performance Qualification) and perform safely. Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Responsible for developing, contributing to, and maintaining Periodic Safety Update Reports (PSURs), Clinical Evaluation Reports (CERs), and Technical Documentation (TD files) in accordance with EU MDR (Medical Device Regulations) requirements. Collaborate with cross functional teams to ensure compliance with global regulatory expectations, support lifecycle mgmt. activities, and maintain up to date clinical, safety, and technical documentation for assigned products. Comply with Production Part Approval Process (PPAP) requirements documentation, including Control Plans (CP), Process Flow (PF), and Material Requirements (MR) for transfer projects. Relocation assistance is not available for this position. #LI-DNI.\nBasic Qualifications:\nRequires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and 2 years of experience as a quality, product or validation engineer.\nMust possess at least two (2) years of experience with each of the following:\nDMAIC methodology; Minitab, DOE, SPC, Variable Gage R & R, ANOVA, t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis; Product and Process risk utilizing FMEA and ISO 14971, A3 thinking, PDCA, 5 Why’s, and Ishikawa (Fishbone); QMS process, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and GDP; IQ/OQ/PQ, CAPA and RCA; PSUR, CER and TD files as per EU MDR and global requirements; and PPAP, CP, PF, MR for transfer projects.\nSalary: $115,000 to $147,600 per year\nThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).\nThe following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).\nRegular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.\nFurther details are available at the link below:\nMedtronic benefits and compensation plans\nRecruitment Fraud Alert\nWe are aware of phishing scams targeting job seekers. Please keep the following in mind:\nApply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.\nMedtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.\nIf you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.\nIf you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at .","description_format":"text","description_chars":5536,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Relocation assistance","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-21T14:41:32Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 251 · green card filings: 131","filings_12m":251,"filings_prev_12m":323,"green_card_filings_12m":131,"median_offered_wage_usd":119463,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+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":18,"band":"cold","label":"Long shot","p_open":1,"p_active":0.646,"p_room":0.28,"age_days":50,"expected_fill_days":19,"reasons":["conf:1","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":147600,"is_top_pay":false},"html_url":"https://alion.io/job/medtronic-sr-design-quality-engineer-2","json_url":"https://alion.io/job/medtronic-sr-design-quality-engineer-2.json","meta":{"generated_at":"2026-11-11T07:06:46Z","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":10562,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"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":638},"rest":"https://alion.io/mcp/rest/get_company?id=638"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmedtronic-sr-design-quality-engineer-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%2Fmedtronic-sr-design-quality-engineer-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%2Fmedtronic-sr-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/medtronic-sr-design-quality-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedtronic-sr-design-quality-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1091818}},{"tool":"search_jobs","arguments":{"company":"medtronic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1091818},"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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