{"id":2683905,"url":"https://alion.io/job/icu-medical-quality-engineer-ii-sustaining-validation","title":"Quality Engineer II, Sustaining & Validation","company":{"id":11675,"name":"ICU Medical","domain":"icumed.com","url":"https://alion.io/company/icu-medical","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":37,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Salt Lake City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":62000,"max_usd":113000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"21 CFR Part 820","optional":true},{"name":"GD&T","optional":true},{"name":"ISO 14971","optional":true},{"name":"Microsoft Office","optional":true},{"name":"Minitab","optional":true}],"status":"live","first_seen_at":"2026-10-09T17:42:03Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-30T22:12:34Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"Position Summary\nThis role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products meet the highest standards of quality and regulatory compliance. The Quality Engineer II, Sustaining will work closely with cross-functional teams, including R&D, Advanced Manufacturing Engineering, Manufacturing, and Quality Assurance, to validate equipment, processes, and software used in production.\nEssential Duties & Responsibilities\nDemonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products. \nDevelop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems.\nConduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation.\nCreate and review Quality Control Plans and process FMEA’s, \nEnsure validation documentation is accurate, complete, and in accordance with regulatory and quality system requirements.\nMaintain validation master plans, protocols, and reports as part of the company’s quality system documentation.\nImprove the Quality Management System through internal audits and supporting regulatory audits.\nLead and support the validation of new and existing manufacturing processes, ensuring compliance with FDA regulations, ISO 13485 standard, and company quality systems.\nDevelop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed\nMust be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform analysis and resolve problems of moderate complexity.\nWrite effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements. \nUpdates Standard Operating Procedures and related QMS documentation, to complete improvement projects, as required.\nEstablish and maintain communication both internal and external (with the customers, molding, automation, assembly, product engineering, project management and regulatory personnel as needed)\nContinually improve knowledge of relevant quality/regulatory topics and changes.\nKnowledge, Skills & Qualifications\nKnowledge of Agile PLM / Oracle (Desirable) \nKnowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts.\nProficient in Minitab and Microsoft Office Suite\nStrong communication skills and the ability to work collaboratively with cross-functional teams.\nAble to multitask and work in a fast-paced environment.\nHigh level of attention to detail and strong organizational skills.\nEducation and Experience\nMust be at least 18 years of age\nBachelor’s degree in STEM from an accredited college or university\n2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment required. Prior experience in quality is preferred.\nProficiency in using validation software and other relevant tools (e.g., Minitab, statistical analysis software).\nStrong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).\nPhysical Requirements and Work Environment\nThis is largely a sedentary role. \nThis job operates in a professional office environment and routinely uses standard office equipment.\nWork is partly performed in a clean room environment\nMust be able to occasionally move and lift objects of up to 25 lbs\nTypically requires travel less than 5% of the time","description_format":"text","description_chars":3602,"description_truncated":false,"requirements":{"experience_years_min":2,"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":[],"lifecycle":[{"event":"open","at":"2026-10-16T07:12:48Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 20 · green card filings: 11","filings_12m":20,"filings_prev_12m":22,"green_card_filings_12m":11,"median_offered_wage_usd":125726,"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":42,"band":"fade","label":"Fading","p_open":1,"p_active":0.566,"p_room":0.75,"age_days":21,"expected_fill_days":26,"reasons":["conf:7","stale_co","win:late","comp:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/icu-medical-quality-engineer-ii-sustaining-validation","json_url":"https://alion.io/job/icu-medical-quality-engineer-ii-sustaining-validation.json","meta":{"generated_at":"2026-10-31T10:14:13Z","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":15604,"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":11675},"rest":"https://alion.io/mcp/rest/get_company?id=11675"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ficu-medical-quality-engineer-ii-sustaining-validation"},{"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%2Ficu-medical-quality-engineer-ii-sustaining-validation"},{"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%2Ficu-medical-quality-engineer-ii-sustaining-validation"},{"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/icu-medical-quality-engineer-ii-sustaining-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ficu-medical-quality-engineer-ii-sustaining-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2683905}},{"tool":"search_jobs","arguments":{"company":"icumed.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2683905},"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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