{"id":2501902,"url":"https://alion.io/job/magenta-med-design-assurance-engineer-2","title":"Design Assurance Engineer","company":{"id":3783058,"name":"Magenta Med","domain":"magentamed.com","url":"https://alion.io/company/world-3783058","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Comeet","truth_index":null},"role":"MedTech","role_family":"MedTech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":62000,"max_usd":124000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":52},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-13T15:45:39Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-31T23:11:07Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"Description\nWe're looking for a Design Quality Assurance Engineer to join our growing Design QA team.\nIn this role, you’ll collaborate closely with R&D, Engineering, and Manufacturing teams to support the design and development process and regulatory compliance.\nAs we continuously evolve our product and processes toward PMA (Pre-Market Approval), this is a unique opportunity to join at a high-impact phase of development.\nResponsibilities\nEnsure that design and development activities are performed in accordance with applicable procedures and approved design and development plans.\nWork closely with project teams to provide quality and compliance input throughout the design and development process.\nReview and approve key design and development deliverables, including requirements, design outputs, and verification and validation documentation.\nSupport Regulatory Affairs activities, including regulatory submissions, responses to regulatory questions, implementation of new or revised standards, and internal and external audits.\nParticipate in project and design review meetings.\nPerform Design Quality activities within the product risk management process, including review and approval of DFMEA and related risk management documentation.\nSupport and accompany Engineering Change Orders (ECOs), including assessment and completion of applicable quality activities.\nProvide Design Quality support for design transfer of new products and sustaining changes to Manufacturing, Operations Quality, and Supplier Quality.\nReports to\nQA Manager\nRequirements\nAt least 3-5 years of experience working in a quality function in the medical device industry - must.\nAt least 2-3 years of experience as a design control engineer (preferred).\nPrior hands-on experience in Verification & Validation (V&V) activities within the medical device industry - a significant advantage.\nA Bachelor of Science in Engineering, Sciences, or a related field - must.\nExperience with ISO 13485, ISO 14971, 21 CFR 820, EU MDR standards - must.\nFamiliar with statistical techniques used in verification and validation processes (preferred).\nStrong analytical and problem-solving skills, with keen attention to detail.\nExcellent communication and interpersonal skills, with the ability to collaborate effectively across functions.\nStrong execution and follow-up skills\nAbility to work in a fast-paced environment\nProficient use of standard MS Office applications.\nFluent in English (oral and written).","description_format":"text","description_chars":2476,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-14T06:12:18Z"}],"visa":[],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.791,"p_room":0.75,"age_days":17,"expected_fill_days":24,"reasons":["conf:1","win:late"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/magenta-med-design-assurance-engineer-2","json_url":"https://alion.io/job/magenta-med-design-assurance-engineer-2.json","meta":{"generated_at":"2026-10-31T23:43:32Z","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":37196,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":3783058},"rest":"https://alion.io/mcp/rest/get_company?id=3783058"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmagenta-med-design-assurance-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%2Fmagenta-med-design-assurance-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%2Fmagenta-med-design-assurance-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/magenta-med-design-assurance-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmagenta-med-design-assurance-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2501902}},{"tool":"search_jobs","arguments":{"company":"magentamed.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2501902},"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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