{"schemaVersion":"jobsearcher.job.v1","id":"b06d302a88c1214415576cbb","url":"https://jobsearcher.com/jobs/b06d302a88c1214415576cbb","canonicalUrl":"https://jobsearcher.com/jobs/b06d302a88c1214415576cbb","title":"Process Development Engineer","description":"Process Development Engineer - Technologies\nThe Process Development Engineer is responsible for developing, documenting, validating, and continuously improving processes supporting balloon manufacturing, injection molding, 3D printing, and pad printing technologies. This role serves as the technical owner for assigned manufacturing technologies and partners closely with Operations, Quality, Engineering, and Production to ensure safe, efficient, and repeatable manufacturing processes that meet quality and regulatory requirements.\nReporting to the Technologies Manager, this position combines hands-on technical work in the clean room with documentation, process development, tooling design, and operator training.\nDuties and Responsibilities\nDevelop, optimize, and sustain manufacturing processes for balloon manufacturing, injection molding, and pad printing.\nAuthor and maintain SOPs, work instructions, manufacturing specifications, and other controlled documentation.\nDesign and build manufacturing tooling and fixtures to improve quality, efficiency, and repeatability.\nLead process qualification activities, including equipment qualification and IQ/OQ/PQ protocol development and execution.\nSupport engineering change activities through DCRs, ECOs, and related documentation.\nAnalyze manufacturing data to identify trends, improve yield, reduce scrap, and increase process capability.\nTrain production operators and technicians on manufacturing processes, equipment, and best practices.\nTroubleshoot manufacturing equipment and process issues to minimize downtime.\nCollaborate with Quality to investigate nonconformances, implement CAPAs, and support root cause analysis.\nParticipate in new product introduction and technology transfer into manufacturing.\nEnsure compliance with ISO 13485, FDA Quality System Regulation, and internal quality procedures.\nSupport continuous improvement initiatives across manufacturing technologies.\nMaintain documentation supporting process validation and manufacturing readiness.\nAssist with equipment setup, qualification, and ongoing process monitoring.\nOther duties as assigned.","company":"Midwest Interventional Systems","rawCompany":"midwest interventional systems","city":"Maple Grove","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-08-05T15:44:02.362Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"}],"industries":[{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"333511","title":"Industrial Mold Manufacturing","slug":"industrial-mold-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer","description":"Process Development Engineer - Technologies\nThe Process Development Engineer is responsible for developing, documenting, validating, and continuously improving processes supporting balloon manufacturing, injection molding, 3D printing, and pad printing technologies. This role serves as the technical owner for assigned manufacturing technologies and partners closely with Operations, Quality, Engineering, and Production to ensure safe, efficient, and repeatable manufacturing processes that meet quality and regulatory requirements.\nReporting to the Technologies Manager, this position combines hands-on technical work in the clean room with documentation, process development, tooling design, and operator training.\nDuties and Responsibilities\nDevelop, optimize, and sustain manufacturing processes for balloon manufacturing, injection molding, and pad printing.\nAuthor and maintain SOPs, work instructions, manufacturing specifications, and other controlled documentation.\nDesign and build manufacturing tooling and fixtures to improve quality, efficiency, and repeatability.\nLead process qualification activities, including equipment qualification and IQ/OQ/PQ protocol development and execution.\nSupport engineering change activities through DCRs, ECOs, and related documentation.\nAnalyze manufacturing data to identify trends, improve yield, reduce scrap, and increase process capability.\nTrain production operators and technicians on manufacturing processes, equipment, and best practices.\nTroubleshoot manufacturing equipment and process issues to minimize downtime.\nCollaborate with Quality to investigate nonconformances, implement CAPAs, and support root cause analysis.\nParticipate in new product introduction and technology transfer into manufacturing.\nEnsure compliance with ISO 13485, FDA Quality System Regulation, and internal quality procedures.\nSupport continuous improvement initiatives across manufacturing technologies.\nMaintain documentation supporting process validation and manufacturing readiness.\nAssist with equipment setup, qualification, and ongoing process monitoring.\nOther duties as assigned.","datePosted":"2026-08-05T15:44:02.362Z","dateModified":"2026-08-05T15:44:02.362Z","hiringOrganization":{"@type":"Organization","name":"Midwest Interventional Systems","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Maple Grove","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b06d302a88c1214415576cbb"},"url":"https://jobsearcher.com/jobs/b06d302a88c1214415576cbb"}}