{"schemaVersion":"jobsearcher.job.v1","id":"b3f279b5bc2f5fdd1fdebad1","url":"https://jobsearcher.com/jobs/b3f279b5bc2f5fdd1fdebad1","canonicalUrl":"https://jobsearcher.com/jobs/b3f279b5bc2f5fdd1fdebad1","title":"Process Engineer","description":"Role Summary\nThe Process Engineer is responsible for the validation, engineering support and continuous improvement of manufacturing processes as well as product in our Cambridge, United Kingdom offices. You must live in this territory and position will be on site Monday - Friday.\n\nThis role requires a mechanical engineering background with hands‑on quality system experience, supporting day‑to‑day production activities while ensuring compliance with ISO 13485, applicable regulatory and internal QMS requirements.\n\nThe Process Engineer works cross‑functionally with Quality Control, Operations and QARA to ensure robust manufacturing processes, effective nonconformance management, and safe, compliant product release.\n\nKey Responsibilities\n\nDay‑to‑Day Quality Support for Production\n\nProvide daily quality engineering support to manufacturing operations\n\nEnsure production activities comply with:\n\nApproved procedures and work instructions\n\nISO 13485 and other applicable requirements\n\nSupport line readiness, start‑up, and troubleshooting\n\nParticipate in production reviews, deviation assessments, and batch disposition support\n\nDesign Changes & Product Improvements\n\nCoordinate and support design changes, design improvements, and process optimisations.\n\nAct as engineering representative for Design Change reviews and risk impact assessments.\n\nEnsure appropriate linkage between Design changes, Manufacturing process updates and Validation and verification activities.\n\nSupport design transfer and continuous improvement initiatives\n\nManufacturing Process Validation & Control\n\nLead and execute manufacturing process validation activities, including IQ/OQ/PQ for production lines and equipment\n\nMaintain validated state of manufacturing processes through change control and revalidation assessments\n\nSupport transfer of validated processes into routine production\n\nNonconformance (NC) & Deviation Management\n\nLead or support investigation of manufacturing‑related nonconformances\n\nCoordinate root cause analysis using structured problem‑solving tools (e.g. 5‑Why, Fishbone)\n\nDefine and support implementation of corrective and preventive actions (CAPA) related to manufacturing processes\n\nInterface with Quality to ensure timely closure and effectiveness verification\n\nCross‑Functional Coordination\n\nWork closely with:\n\nPurchasing: support supplier quality issues related to manufacturing inputs\n\nQC Lab: support test method issues, failures, and investigations\n\nWarehouse: support material handling, traceability, and segregation of nonconforming product\n\nRepairs & Returns: analyse returned units and feed results into process improvements\n\nTechnical Services: support field‑reported manufacturing issues\n\nProvide technical and quality input for supplier‑related issues impacting manufacturing\n\nDocumentation & Compliance\n\nAuthor and review controlled documents such as SOPs, Work Instructions, etc.\n\nSupport internal and external audits by providing process‑level evidence and explanations\n\nRequired Qualifications & Experience\nEducation\n\nBachelor's degree in Mechanical Engineering (or equivalent engineering discipline).\n\nExperience\n\nExperience in medical device or IVD manufacturing, strongly preferred or exposure to EU IVDR requirements.\n\nHands‑on experience with:\n\nProduction support in a regulated environment\n\nManufacturing process validation (IQ/OQ/PQ)\n\nQuality systems (ISO 13485)\n\nSupplier quality management\n\nExperience supporting:\n\nNonconformance investigations\n\nChange control and design changes\n\nAbility to support ISO/ MDSAP/ regulatory audits\n\nStructured problem‑solving mindset\n\nAbility to work independently in a fast‑paced manufacturing environment\n\nComfortable interacting with Quality, Engineering, and Operations teams\n\n#J-18808-Ljbffr","company":"Harvard Bioscience","rawCompany":"harvard bioscience","city":"Somerville","state":"MA","isRemote":false,"isActive":true,"createdAt":"2026-06-28T04:12:00.326Z","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":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Role Summary\nThe Process Engineer is responsible for the validation, engineering support and continuous improvement of manufacturing processes as well as product in our Cambridge, United Kingdom offices. You must live in this territory and position will be on site Monday - Friday.\n\nThis role requires a mechanical engineering background with hands‑on quality system experience, supporting day‑to‑day production activities while ensuring compliance with ISO 13485, applicable regulatory and internal QMS requirements.\n\nThe Process Engineer works cross‑functionally with Quality Control, Operations and QARA to ensure robust manufacturing processes, effective nonconformance management, and safe, compliant product release.\n\nKey Responsibilities\n\nDay‑to‑Day Quality Support for Production\n\nProvide daily quality engineering support to manufacturing operations\n\nEnsure production activities comply with:\n\nApproved procedures and work instructions\n\nISO 13485 and other applicable requirements\n\nSupport line readiness, start‑up, and troubleshooting\n\nParticipate in production reviews, deviation assessments, and batch disposition support\n\nDesign Changes & Product Improvements\n\nCoordinate and support design changes, design improvements, and process optimisations.\n\nAct as engineering representative for Design Change reviews and risk impact assessments.\n\nEnsure appropriate linkage between Design changes, Manufacturing process updates and Validation and verification activities.\n\nSupport design transfer and continuous improvement initiatives\n\nManufacturing Process Validation & Control\n\nLead and execute manufacturing process validation activities, including IQ/OQ/PQ for production lines and equipment\n\nMaintain validated state of manufacturing processes through change control and revalidation assessments\n\nSupport transfer of validated processes into routine production\n\nNonconformance (NC) & Deviation Management\n\nLead or support investigation of manufacturing‑related nonconformances\n\nCoordinate root cause analysis using structured problem‑solving tools (e.g. 5‑Why, Fishbone)\n\nDefine and support implementation of corrective and preventive actions (CAPA) related to manufacturing processes\n\nInterface with Quality to ensure timely closure and effectiveness verification\n\nCross‑Functional Coordination\n\nWork closely with:\n\nPurchasing: support supplier quality issues related to manufacturing inputs\n\nQC Lab: support test method issues, failures, and investigations\n\nWarehouse: support material handling, traceability, and segregation of nonconforming product\n\nRepairs & Returns: analyse returned units and feed results into process improvements\n\nTechnical Services: support field‑reported manufacturing issues\n\nProvide technical and quality input for supplier‑related issues impacting manufacturing\n\nDocumentation & Compliance\n\nAuthor and review controlled documents such as SOPs, Work Instructions, etc.\n\nSupport internal and external audits by providing process‑level evidence and explanations\n\nRequired Qualifications & Experience\nEducation\n\nBachelor's degree in Mechanical Engineering (or equivalent engineering discipline).\n\nExperience\n\nExperience in medical device or IVD manufacturing, strongly preferred or exposure to EU IVDR requirements.\n\nHands‑on experience with:\n\nProduction support in a regulated environment\n\nManufacturing process validation (IQ/OQ/PQ)\n\nQuality systems (ISO 13485)\n\nSupplier quality management\n\nExperience supporting:\n\nNonconformance investigations\n\nChange control and design changes\n\nAbility to support ISO/ MDSAP/ regulatory audits\n\nStructured problem‑solving mindset\n\nAbility to work independently in a fast‑paced manufacturing environment\n\nComfortable interacting with Quality, Engineering, and Operations teams\n\n#J-18808-Ljbffr","datePosted":"2026-06-28T04:12:00.326Z","dateModified":"2026-06-28T04:12:00.326Z","hiringOrganization":{"@type":"Organization","name":"Harvard Bioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerville","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b3f279b5bc2f5fdd1fdebad1"},"url":"https://jobsearcher.com/jobs/b3f279b5bc2f5fdd1fdebad1"}}