{"id":3844229,"url":"https://alion.io/job/getinge-sr-engineer-rd-capa-wayne-nj","title":"Sr. Engineer, R&D CAPA - Wayne, NJ","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":{"grade":"A","score":100,"open_postings":13,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-11-07T05:47:08Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Wayne, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-06T00:08:37Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-07T21:29:50Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"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.\nJob Overview\nThe Senior R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.\nOperating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.\nJob Responsibilities and Essential Duties\nLead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.\nPerform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.\nDevelop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.\nEnsure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.\nCollaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.\nProvide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.\nSupport CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.\nSupport internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.\nMaintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.\nIdentify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.\nServe as a technical CAPA subject matter expert within the R&D organization.\nMinimum Requirements\n\nBachelor’s degree in Engineering or related technical discipline; advanced degree preferred.\n5+ years of experience in R&D engineering within a medical device organization.\nDemonstrated experience managing and executing CAPA activities within product design and development.\nStrong understanding of regulatory requirements, including FDA regulations and ISO 13485.\nRequired Knowledge, Skills and Abilities\nExpert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.\nStrong analytical and problem-solving skills with exceptional attention to detail.\nAbility to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.\nEffective verbal and written communication skills for presenting findings across all organizational levels.\nExperience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.\nProficiency with CAPA and documentation systems; TrackWise experience preferred.\nIn-depth knowledge of medical device regulations, design control processes, and quality system expectations.\nSalary range: $115k - $140k; 10% STIP\n#LI-LG1 #LI-hybrid\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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