{"id":3307307,"url":"https://alion.io/job/medtronic-principal-quality-engineer","title":"Principal 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":93,"open_postings":142,"ghost_share":0.021,"stale_share":0.387,"repost_share":0.07,"time_to_fill_p50_days":19,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Grand Rapids, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":121000,"max":181200,"currency":"USD","period":"year","gross":null,"usd_annual":181200},"salary_estimate":null,"experience_years_min":5,"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":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"Minitab","optional":false},{"name":"Power BI","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-29T22:04:35Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"We anticipate the application window for this opening will close on - 31 Dec 2026Position Description:\nPrincipal Quality Engineer for Medtronic, Inc. in Grand Rapids, MI. Responsible for products in the form of finished medical devices by supporting manufacturing operations and evaluating compliance of materials and processes with product specifications, regulatory requirements, and customer requirements. Coordinate Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Leverage Good Manufacturing Practices (GMP) standards, navigate government and medical device regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA). Coordinate and support internal and external audits conducted at the facility. Conduct Risk Assessments, Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA). Responsible for Non-Conformances, Complaints, and Corrective and Preventive Actions (CAPA). Utilize Process Improvement tools, including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5 Whys, Fishbone, and cause mapping. Contribute to Business Value stream Mapping (VSM) initiatives and support process flow strategy areas to drive quality excellence and process compliant stability. Coordinate Design of Experiments (DOE) methods for process development and statistical analysis tools for process capability (Cpk/Ppk), ANOVA, Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Coordinate V&V (verification and validation) protocols, including Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, and PQ). Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making. Coordinate product lifecycle mgmt. efforts, including overseeing quality systems and authoring technical documentation. Leverage First Time Quality (FTQ) principles to enhance process improvement and drive strategic initiatives. Position is required to be onsite in Grand Rapids, MI, at least 4 days a week. Relocation assistance is not available for this position. #LI-DNI.\nBasic Qualifications:\nMaster’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related engineering field and five (5) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering;\nOR\nBachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering management or related engineering field and seven (7) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering.\nMust possess at least five (5) years’ experience with each of the following:\nGMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, cause mapping, and VSM; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; Lean - Six Sigma; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; and FTQ principles.\nSalary: $121,000 to $181,200 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":5366,"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":["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":"2026-10-27T01:58:26Z"}],"visa":[{"country":"US","licensed_sponsor":true,"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":"2026-10-29T16:27:21+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":89,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.888,"p_room":1,"age_days":3,"expected_fill_days":19,"reasons":["conf:4","velocity","win:early","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":181200,"is_top_pay":true},"html_url":"https://alion.io/job/medtronic-principal-quality-engineer","json_url":"https://alion.io/job/medtronic-principal-quality-engineer.json","meta":{"generated_at":"2026-10-29T22:33:18Z","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":33360,"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":638},"rest":"https://alion.io/mcp/rest/get_company?id=638"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmedtronic-principal-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%2Fmedtronic-principal-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%2Fmedtronic-principal-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/medtronic-principal-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedtronic-principal-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3307307}},{"tool":"search_jobs","arguments":{"company":"medtronic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3307307},"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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