{"id":3413263,"url":"https://alion.io/job/getinge-design-quality-engineer","title":"Design Quality Engineer","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":8,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":25,"computed_at":"2026-10-30T05:48:23Z"}},"role":"MedTech","role_family":"MedTech","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":171000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":31},"experience_years_min":1,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false},{"name":"JMP","optional":true},{"name":"Microsoft Office","optional":true},{"name":"Minitab","optional":true},{"name":"Statistical Process Control","optional":true}],"status":"live","first_seen_at":"2026-10-28T18:33:32Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-10-29T04:10:51Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"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.\nParagonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.\nPosition Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix’s medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including Sustaining Engineering, R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.\nPrimary responsibilities/authority will include:\nDesign Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.\nRisk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.\nQuality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.\nDesign Input and Output:Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.\nValidate that design outputs meet the specified design input requirements.\n\nChange Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.\nVerification and Validation:Develop and execute protocols for design verification and validation strategies and acceptance criteria.\nCollaborate with testing teams to ensure thorough testing of product designs.\n\nCollaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.\nRegulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.\nContinuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.\nFailure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.\nRequired Qualifications:\nBachelor's degree in engineering or a related field; advanced degree preferred.\nMinimum of 1-3 years of experience in a quality engineering role in the medical device industry.\nIn-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).\nStrong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.\nStrong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).\nExcellent communication and interpersonal skills, with the ability to collaborate effectively across functions.\nDFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.\nOther Requirements:\nElectrical and mechanical background strongly preferred.\nExperience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.\nKnowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.\nComputer proficiency in MS office (specifically Excel).\nEffective verbal and excellent technical writing skills.\nExcels at generating and maintaining organized and accurate records.\nExcellent oral and written communication skills in English.\nAble to travel domestically and internationally as required (Able to work in the US without sponsorship now or any time in the future.\nUS BASED SALARY - The base salary range for this role is $100,000 - $110,000 plus 5% in 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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