{"id":3127891,"url":"https://alion.io/job/stryker-staff-design-quality-engineer","title":"Staff Design Quality Engineer","company":{"id":2579,"name":"Stryker","domain":"stryker.com","url":"https://alion.io/company/stryker","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":143,"ghost_share":0,"stale_share":0.72,"repost_share":0.021,"time_to_fill_p50_days":32,"computed_at":"2026-10-27T05:46:45Z"}},"role":"MedTech","role_family":"MedTech","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":93200,"max":155400,"currency":"USD","period":"year","gross":null,"usd_annual":155400},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-27T07:40:00Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Work Flexibility: HybridStaff Design Quality Engineer\nWaltham - MA\nJoin Stryker as a Staff Design Quality Engineer supporting new product development and quality activities throughout the medical device product lifecycle. In this role, you will partner with Research & Development, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to support design controls, risk management, product verification and validation, design transfer, and Quality Management System compliance in a regulated medical device environment.\nWork Flexibility:\nHybrid: candidates must reside within commuting distance of Waltham - MA and be able to work onsite several days per week.\nWhat you will do\nRepresent Quality Engineering on cross-functional new product development teams, providing quality and regulatory guidance throughout the product lifecycle.\nReview and approve design control documentation, including design plans, user needs, design inputs and outputs, verification and validation protocols and reports, design reviews, and Design History File documentation.\nApply risk management principles in accordance with ISO 14971 and participate in design reviews and product risk assessments.\nSupport verification, validation, process validation, and design transfer activities to ensure established requirements and acceptance criteria are addressed.\nEvaluate product requirements, specifications, engineering changes, and manufacturing changes for quality and regulatory impact.\nInvestigate product and development issues using root cause analysis and support corrective and preventive actions, nonconformances, change control, and complaint investigations.\nMaintain quality documentation and records in accordance with ISO 13485, FDA 21 CFR Part 820, and applicable global medical device requirements.\nSupport internal and regulatory audits, supplier quality activities, regulatory submissions, and updates to quality procedures, work instructions, and quality system requirements.\nWhat you will need\nRequired\nBachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.\nMinimum 4 years of experience in Quality Engineering, Quality Assurance, or a related position within the medical device industry.\nExperience supporting new product development, including design control activities.\nWorking knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, design controls, corrective and preventive action, change management, and process validation.\nExperience using electronic Quality Management Systems.\nPreferred\nCertified Quality Engineer (CQE) certification or a comparable quality certification.\nExperience with Class II and/or Class III medical devices, including global requirements such as the European Union Medical Device Regulation and Medical Device Single Audit Program.\nExperience with statistical analysis, quality improvement methodologies, supplier quality management, auditing, software validation, or computerized system validation.\nUS20: $93,200 - $155,400 USD Annual\nTravel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.","description_format":"text","description_chars":4177,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Neurotech & Neuromodulation","Hospital Equipment & Furniture"],"lifecycle":[{"event":"open","at":"2026-10-23T02:42:23Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 73 · green card filings: 27","filings_12m":73,"filings_prev_12m":92,"green_card_filings_12m":27,"median_offered_wage_usd":133850,"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":57,"band":"ok","label":"Likely open","p_open":0.9,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":32,"reasons":["conf:72","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":155400,"is_top_pay":true},"html_url":"https://alion.io/job/stryker-staff-design-quality-engineer","json_url":"https://alion.io/job/stryker-staff-design-quality-engineer.json","meta":{"generated_at":"2026-10-27T10:52:53Z","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":12764,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":2579},"rest":"https://alion.io/mcp/rest/get_company?id=2579"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fstryker-staff-design-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%2Fstryker-staff-design-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%2Fstryker-staff-design-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/stryker-staff-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fstryker-staff-design-quality-engineer"}]}