{"id":3560809,"url":"https://alion.io/job/getinge-engineer-i-production","title":"Engineer I, Production","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":7,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","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":null,"salary_estimate":{"min_usd":54000,"max_usd":98000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4343},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"Windows","optional":true}],"status":"live","first_seen_at":"2026-10-29T00:00:00Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-10-31T08:30:44Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"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 primary responsibility for this Engineer I, Production position will be reviewing production documentation and addressing deficiencies found, performing equipment qualifications, and other improvements related to compliance issues. Lead and execute process validation requirements in parallel with identifying and implementing improvement and cost elimination projects for manufacturing. This position will report to the Supervisor, Manufacturing Engineering.\nJob Responsibilities and Essential Duties\nInitiate Design Changes and Change Notices to document changes being implemented.\nWrite and execute validation protocols, to demonstrate acceptability of a proposed change. Compile and analyze protocol test data.\nReview procedures and determine whether they are being followed. Implement changes as needed. (Engineering specifications, change notices, manufacturing procedures, equipment registrations and other documentation).\nComply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.\nSupport efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Regulation (MDR) and European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.\nAssess and Implement solutions relating to corrective and preventative actions, calibration out of tolerances, non-conformances.\nThis is not an inclusive list of job responsibilities.\nMinimum Requirements\nBachelor of Science degree, preferably in Biomedical, Mechanical, Manufacturing Engineering or equivalent with 0-2 years of related experience.\nGeneral understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.\nExperience working in a regulated environment preferred\nExperience with Windchill software a plus\nFormal training and/or experience in process validations/qualifications and statistics a plus.\nRequired Knowledge, Skills, and Abilities\nStrong technical and analytical ability, ingenuity. Detail oriented.\nMust be a good communicator, both verbal and written communication skills, with good interpersonal skills.\nGood organizational skills. Must be able to adhere to timelines.\nComputer skills including, but not limited to: Microsoft Windows, Word, Excel.\nFamiliarity with statistical analysis.\nProject Management.\nThis role is a hybrid position based in Wayne, NJ with a few days a week required in office.\nPay rate: $88,000 - $92,000 / year + 8% annual bonus\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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