{"id":3361175,"url":"https://alion.io/job/icu-medical-senior-engineer-quality","title":"Senior Engineer, Quality","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":33,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gary, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":76000,"max_usd":143000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":7,"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":"EU MDR","optional":false},{"name":"IEC 60601","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-10-27T16:58:13Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-01T11:12:28Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Position Summary\nProvide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.\nEssential Duties & Responsibilities\nEnsure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.\nEnsure compliance, alignment and consistency with ICU Medical’s quality system and development practices.\nEffectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.\nPrepare, support and ensure the readiness for any potential internal and/or external audits and inspections. \nPerform periodic audits of projects against SOP’s and process.\nParticipate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.\nReview, approve and participate in qualification of acquired software and software tools.\nPerform and support product risk analysis and management.\nUtilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. \nMonitor product data to identify statistically significant trends and risks.\nSupport on-market issue investigations, risk assessments and associated CAPA activities.\nReview and approve resolution of on-market product issues.\nSupport regulatory submissions and responses to regulatory inquires.\nWork special projects as assigned\nKnowledge & Skills\nExpert quality compliance, audit, and investigation skills\nIn depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)\nStrong knowledge of medical device standards, including but not limited to:ISO 13485\nISO 14971\nIEC 60601\nIEC 62304\n\nIn depth experience with and knowledge of FDA, MDR, and other key medical device regulations\nWell-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)\nProven ability to work closely with engineering teams and members of a cross functional team\nNew product development experience is strongly preferred.\nMinimum Qualifications, Education & Experience\nMust be at least 18 years of age\nBachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.\nMinimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry\nASQ CQE or CSQE required or the ability to obtain within one year.\nWork Environment\nThis is largely a sedentary role. \nThis job operates in a professional office environment and routinely uses standard office equipment.\nTypically requires travel 5% to 10% of the time","description_format":"text","description_chars":3597,"description_truncated":false,"requirements":{"experience_years_min":7,"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":["Respiratory & Sleep Devices","Medical Supplies & Consumables","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-27T21:23:35Z"}],"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: 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