{"schemaVersion":"jobsearcher.job.v1","id":"e36f4bebbd96e83a1ba438fd","url":"https://jobsearcher.com/jobs/e36f4bebbd96e83a1ba438fd","canonicalUrl":"https://jobsearcher.com/jobs/e36f4bebbd96e83a1ba438fd","title":"Sr. Engineer, Process Development - Wayne, NJ","description":"Date: Jul 14, 2026\n\nLocation:\nWayne, NJ, US\n\nCompany: Maquet Cardiovascular LLC\nRemote Work: 1-2 days at home (site based)\nSalary Range: $115,000 - $135,000 per year depending on experien\n\nWith a passion for life\n\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.\n\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\n\nThis position provides technical leadership in development, optimization, validation, and design transfer of medical device manufacturing processes from R&D into commercial production\nThis role ensures that processes are robust, scalable, and compliant with regulatory and quality standards including FDA 21 CFR Part 820 and ISO 13485.\nLeadership in process development, validation, statistical analysis, and cross-functional collaboration, with a proven ability to drive successful product introductions in a regulated environment.\n\nJob Responsibilities and Essential Duties\n\nProcess Development\n\nTechnical and team leadership in the development, characterization and optimization of manufacturing processes for new and existing products.\nSupports the definition and development of product requirements, specifications and working parameters using current engineering methods and technologies.\nLead large scale process validations strategies (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations.\nApply DFSS tools (DOE, SPC, capability analysis) to improve process performance and robustness.\n\nDesign Transfer\n\nResponsible for the design transfer activities from R&D to Manufacturing, ensuring readiness for commercial production.\nPartner with a cross-functional team to ensure designs are manufacturable, scalable, and cost-effective (DFM/DFA).\nSupport product launches, including pilot builds and ramp-to-production activities\nEnsure compliance with FDA, ISO 13485 and internal quality systems.\nConduct and support risk management activities (FMEA, hazard analysis).\nParticipate in audits and inspections, providing technical expertise and documentation support.\n\nCross-Functional Collaboration\n\nAct as the primary technical interface in a cross-functional team as a Core Team member\nPartner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity.\nProvide guidance and mentorship to junior engineers and technicians.\n\nContinuous Improvement\n\nIdentify and drive process improvement initiatives using Lean and Six Sigma methodologies.\nMonitor and analyze process performance metrics to improve yield, reduce scrap, and increase efficiency.\nSupport CAPA investigation and implement sustainable solutions.\n\nMinimum Requirements\n\nMaster’s (Preferred) or bachelor’s degree in Mechanical, Biomedical Engineering or related technical field with 5 – 7 years of experience.\nDemonstrated experience in Process Development and Design Transfer in the medical device industry or equivalent.\nCertification in Six Sigma Black Belt or Green Belt\n\nRequired Knowledge, Skills and Abilities\n\nHands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.\nProficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods.\nStrong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies.\nKnowledge of polymer processing, metal fabrication, laser welding or additive manufacturing.\nExperience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.)\nAbility to communicate within the discipline and with others who are not technically trained\nAbility to prioritize tasks in a fast-paced environment.\n\nSupervision/Management Of Others:\nIntern, Co-op, Engineer I and/or II\n\nInternal and External Contacts/Relationships\n\nInteracts with others in and across departments/sites and external contacts (suppliers, test laboratories)\n\nEnvironmental/Safety/Physical Work Conditions\n\nResponsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimize the effects on the environment.\nResponsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.\nResponsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.\nMust be capable of performing system level testing at the home office or at outside labs.\nInvolves sitting 60% of the time, walking 20% and standing 20%.\nWork is performed in an office 35% of the time, engineering lab 45%, and at an outside test lab 20%.\nWork in the office environment involves use of a personal computer 80% of the time with the remainder spent conferring with colleagues and reviewing other documents.\n\nThe salary range for this position is between $115,000 and $135,000 per year depending on experience.\n\n#LI-MV1\n\nAbout us\n\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.\n\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\n\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\n\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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.","company":"Maquet Cardiovascular","rawCompany":"maquet cardiovascular","city":"Wayne","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-08-04T20:38:33.287Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Engineer, Process Development - Wayne, NJ","description":"Date: Jul 14, 2026\n\nLocation:\nWayne, NJ, US\n\nCompany: Maquet Cardiovascular LLC\nRemote Work: 1-2 days at home (site based)\nSalary Range: $115,000 - $135,000 per year depending on experien\n\nWith a passion for life\n\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.\n\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\n\nThis position provides technical leadership in development, optimization, validation, and design transfer of medical device manufacturing processes from R&D into commercial production\nThis role ensures that processes are robust, scalable, and compliant with regulatory and quality standards including FDA 21 CFR Part 820 and ISO 13485.\nLeadership in process development, validation, statistical analysis, and cross-functional collaboration, with a proven ability to drive successful product introductions in a regulated environment.\n\nJob Responsibilities and Essential Duties\n\nProcess Development\n\nTechnical and team leadership in the development, characterization and optimization of manufacturing processes for new and existing products.\nSupports the definition and development of product requirements, specifications and working parameters using current engineering methods and technologies.\nLead large scale process validations strategies (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations.\nApply DFSS tools (DOE, SPC, capability analysis) to improve process performance and robustness.\n\nDesign Transfer\n\nResponsible for the design transfer activities from R&D to Manufacturing, ensuring readiness for commercial production.\nPartner with a cross-functional team to ensure designs are manufacturable, scalable, and cost-effective (DFM/DFA).\nSupport product launches, including pilot builds and ramp-to-production activities\nEnsure compliance with FDA, ISO 13485 and internal quality systems.\nConduct and support risk management activities (FMEA, hazard analysis).\nParticipate in audits and inspections, providing technical expertise and documentation support.\n\nCross-Functional Collaboration\n\nAct as the primary technical interface in a cross-functional team as a Core Team member\nPartner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity.\nProvide guidance and mentorship to junior engineers and technicians.\n\nContinuous Improvement\n\nIdentify and drive process improvement initiatives using Lean and Six Sigma methodologies.\nMonitor and analyze process performance metrics to improve yield, reduce scrap, and increase efficiency.\nSupport CAPA investigation and implement sustainable solutions.\n\nMinimum Requirements\n\nMaster’s (Preferred) or bachelor’s degree in Mechanical, Biomedical Engineering or related technical field with 5 – 7 years of experience.\nDemonstrated experience in Process Development and Design Transfer in the medical device industry or equivalent.\nCertification in Six Sigma Black Belt or Green Belt\n\nRequired Knowledge, Skills and Abilities\n\nHands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.\nProficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods.\nStrong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies.\nKnowledge of polymer processing, metal fabrication, laser welding or additive manufacturing.\nExperience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.)\nAbility to communicate within the discipline and with others who are not technically trained\nAbility to prioritize tasks in a fast-paced environment.\n\nSupervision/Management Of Others:\nIntern, Co-op, Engineer I and/or II\n\nInternal and External Contacts/Relationships\n\nInteracts with others in and across departments/sites and external contacts (suppliers, test laboratories)\n\nEnvironmental/Safety/Physical Work Conditions\n\nResponsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimize the effects on the environment.\nResponsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.\nResponsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.\nMust be capable of performing system level testing at the home office or at outside labs.\nInvolves sitting 60% of the time, walking 20% and standing 20%.\nWork is performed in an office 35% of the time, engineering lab 45%, and at an outside test lab 20%.\nWork in the office environment involves use of a personal computer 80% of the time with the remainder spent conferring with colleagues and reviewing other documents.\n\nThe salary range for this position is between $115,000 and $135,000 per year depending on experience.\n\n#LI-MV1\n\nAbout us\n\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.\n\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\n\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\n\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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.","datePosted":"2026-08-04T20:38:33.287Z","dateModified":"2026-08-04T20:38:33.287Z","hiringOrganization":{"@type":"Organization","name":"Maquet Cardiovascular","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wayne","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e36f4bebbd96e83a1ba438fd"},"url":"https://jobsearcher.com/jobs/e36f4bebbd96e83a1ba438fd"}}