{"id":2684039,"url":"https://alion.io/job/icu-medical-engineer-iii-sustaining","title":"Engineer III, Sustaining","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":"2026-11-05T05:54:30Z"}},"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":["Dublin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":58000,"max_usd":106000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Project","optional":false},{"name":"Minitab","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-08-04T14:28:06Z","employer_posted_date":"2026-08-04","last_verified_at":"2026-11-06T03:06:36Z","board_verified":true,"closed_at":null,"days_open":93,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":93},"description":"Position Summary\nThe Sustaining Engineer is responsible for leading cross-functional projects and engineering initiatives that support the continued manufacture, regulatory compliance, and supply of commercialized medical devices. This role serves as a key liaison between Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external suppliers to evaluate, implement, and document product, component, material, and packaging changes.\nThe Sustaining Engineer drives timely resolution of technical and supply-related challenges affecting on-market products by developing risk-based solutions, coordinating design and validation activities, and executing change management processes. This position plays a critical role in ensuring continuity of supply, product quality, and compliance with applicable regulatory requirements.\nEssential Duties and Responsibilities:\nSustaining Engineering & Product Lifecycle Management\nLead cross-functional projects supporting on-market products, ensuring clear ownership, action plans, milestones, risk mitigation strategies, and successful project execution.\nResolve product, component, material, and packaging issues that could impact the continuity of supply for commercialized products.\nInvestigate technical issues and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supplier Quality teams to develop and implement effective solutions.\nSupport product lifecycle management activities, including design updates, risk assessments, documentation revisions, and product improvements.\nChange Management\nPrepare, coordinate, and execute engineering change activities to support product, component, material, and packaging updates.\nDevelop and maintain documentation including:Engineering Change Orders (ECOs)\nCommodity Specifications\nTechnical Drawings\nChange Control Plans\nDesign and Development Plans\nTechnical Assessments and Reports\n\nEnsure all changes are implemented in accordance with quality system requirements and regulatory expectations.\nSupplier & Component Management\nPartner with Supplier Quality and Supply Chain teams to assess Supplier Change Notifications (SCNs) and evaluate the impact of supplier-driven changes.\nCoordinate technical assessments and testing associated with changes to resins, components, packaging materials, and other supplied products.\nCollaborate with suppliers and internal stakeholders to mitigate risks and maintain uninterrupted product supply.\nValidation & Verification\nCoordinate and support product verification, validation, and qualification activities associated with design, component, material, and packaging changes.\nPrepare and execute validation protocols and reports, including:Packaging Validations\nAccelerated Aging Studies\nMaterial Assessments\nDesign Verification Testing\n\nPartner with Quality and Regulatory teams to ensure compliance with applicable standards and internal requirements.\nCommunication & Reporting\nProvide regular project updates to management and key stakeholders regarding timelines, risks, contingency plans, and project status.\nPrepare technical reports, presentations, data analyses, graphs, and project documentation to support decision-making and regulatory compliance.\nFacilitate effective communication among cross-functional teams, suppliers, and manufacturing sites.\nCompliance & Continuous Improvement\nEnsure compliance with FDA, ISO, cGMP, and internal quality system requirements related to medical device manufacturing.\nFollow applicable procedures, work instructions, and regulatory requirements governing design changes and sustaining engineering activities.\nParticipate in continuous improvement initiatives that enhance product quality, supply reliability, and operational efficiency.\nPerform other sustaining engineering and project-related responsibilities as assigned. \nKnowledge, Skills, and Abilities\nStrong understanding of medical device manufacturing and/or pharmaceutical regulated environments, including FDA regulations, cGMP requirements, and documentation practices.\nKnowledge of medical device packaging systems, packaging validation, and accelerated aging methodologies.\nExperience managing engineering change processes within a regulated manufacturing environment.\nProficiency in statistical analysis and problem-solving tools, including Minitab.\nAbility to interpret technical drawings, specifications, engineering standards, and test methods.\nWorking knowledge of SolidWorks or similar CAD software.\nExperience with project planning and tracking tools, including Microsoft Project.\nStrong analytical and problem-solving skills with the ability to assess technical and business impacts of change.\nExcellent written and verbal communication skills with the ability to interact effectively across all levels of the organization and with external suppliers.\nAbility to manage multiple projects and priorities in a fast-paced, regulated environment.\nUnderstanding of design controls, risk management, and product lifecycle management principles. \nMinimum Qualifications\nEducation\nBachelor’s degree in engineering from an accredited college or university required.\nExperience\nMinimum of 5 years of experience in the medical device industry, or a combination of medical device and pharmaceutical industry experience or other relevant experience.\nExperience supporting product changes, validation activities, and regulated manufacturing processes preferred.\nOther Requirements\nMust be at least 18 years of age. \nWork Environment\nWork is performed in both office and manufacturing environments, including cleanroom operations and automated production areas.\nRegular interaction with manufacturing personnel, technical teams, and suppliers is required.\nPosition may require visits to manufacturing sites and supplier facilities; strong customer-facing and professional communication skills are essential.\nAbility to work in production and laboratory environments as needed to support testing, validation, and process investigations.\nTravel is typically less than 10%.","description_format":"text","description_chars":6046,"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":[],"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: 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