{"id":1791246,"url":"https://alion.io/job/getinge-risk-management-engineer-quality-defined-term","title":"Risk Management Engineer, Quality - Defined Term","company":{"id":719311,"name":"Getinge","domain":"getinge.com","url":"https://alion.io/company/getinge-2","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"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":["Fraser, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96240,"max":120300,"currency":"USD","period":"year","gross":null,"usd_annual":120300},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-02T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-06T01:29:21Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"With a passion for life\nJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\nThe primary purpose of this position is to establish, maintain, and continuously improve product and process risk management activities throughout the medical device lifecycle. The Risk Management Engineer serves as the subject matter expert for ISO 14971 risk management processes and is responsible for development and maintenance of Risk Management Files (RMFs), hazard analyses, risk assessments, and risk-related documentation to ensure compliance with applicable regulatory requirements and company procedures. This role partners closely with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain functions to ensure product risks are appropriately identified, evaluated, controlled, and monitored throughout the product lifecycle.\nThis is a “Defined Term” assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.\n\nJob Responsibilities and Essential Duties:\nPerform all activities in compliance with the Quality Management System (QMS), FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and other applicable regulatory requirements.\nEstablish, maintain, remediate, and continuously improve Risk Management Files for medical devices throughout product development and commercialization.\nLead product risk assessments including Hazard Analysis, Design FMEA (dFMEA), Process FMEA (pFMEA), Use-Related Risk Analysis, and post-market risk evaluations.\nFacilitate cross-functional risk management activities with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain .\nIdentify hazards, foreseeable misuse, hazardous situations, and potential harms associated with medical devices.\nEvaluate risk acceptability and ensure implementation of appropriate risk control measures.\nVerify and document effectiveness of risk control measures and residual risk acceptability.\nEnsure traceability between identified hazards, risk controls, design requirements, verification activities, complaints, CAPAs, and post-market surveillance data.\nMay participate in complaint investigations, nonconformance investigations, CAPAs, supplier quality issues, and root cause analysis activities to assess product risk impacts.\nMonitor post-market surveillance data including complaints, customer feedback, nonconformities, service reports, and adverse events to identify emerging risks.\nSupport internal, external, FDA, Notified Body, and corporate audits related to risk management documentation and processes.\nDevelop and deliver risk management training to employees across the organization.\nSupport the development and maintenance of risk management procedures, work instructions, and templates.\nAssist management with ongoing quality improvement initiatives and risk-based decision-making activities.\nMay be required to perform other duties as assigned or as needed.\nRequired Knowledge, Skills and Abilities: \nProficiency in technical documentation and oral and written communication skills\nKnowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.\nStrong knowledge of ISO 14971 medical device risk management principles and methodologies.\nExperience facilitating and documenting DFMEA, PFMEA, UFMEA, Hazard Analysis, Fault Tree Analysis (FTA), and risk-benefit assessments.\nStrong knowledge in regulatory requirements for the medical device industry, particularly working experience in design control.\nCapable of effectively interfacing with cross-functional team members in achieving common goals.\nAttention to detail and high level of accuracy.\nGood organizational skills and the ability to handle multiple projects at once.\nProficiency with Microsoft Office applications and electronic quality management systems (eQMS).\nMinimum Requirements:\nRequires a Bachelor's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 5+ years of experience in medical device manufacturing, product development, quality engineering, or risk management. \nOR\nRequires a Master's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 3+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.\nQuality Requirements: \nBuild Quality into all aspects of their work by maintaining compliance to all quality requirements.\nEnsure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).\nMust have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).\nAttend all required Quality & Compliance training at the specified interval.\nAdopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.\nEnvironmental/Safety/Physical Work Conditions: \nStanding and or sitting for long periods of time.\nThe physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\n\nThe salary range for this position is between $96,240-$120,300 per year depending on experience\nAbout us\nWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\nHealth, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement\nGetinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. 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