{"schemaVersion":"jobsearcher.job.v1","id":"70a75b7683e7e9b1d9cbde3b","url":"https://jobsearcher.com/jobs/70a75b7683e7e9b1d9cbde3b","canonicalUrl":"https://jobsearcher.com/jobs/70a75b7683e7e9b1d9cbde3b","title":"Process Engineer","description":"Job Title: Process Engineer\nLocation: Waltham, Massachusetts\nType: Contract\nCompensation: $45.00 - $51.00 per hour\nWork Model: Onsite\n\nJoin a leading global medical technology organization focused on life-changing healthcare innovation and high-quality manufacturing excellence. This contract opportunity is ideal for an experienced manufacturing/process engineer with expertise in medical device process development, validation, and optimization, offering hands‑on involvement with advanced capital equipment, statistical analysis, and complex catheter‑based manufacturing processes in a highly collaborative, regulated environment.\n\nResponsibilities\n\nSupport medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ), with a focus on capital equipment\n\nSupport both internally developed and externally sourced manufacturing processes within regulated environments\n\nApply statistical methods and data‑driven problem‑solving techniques, including DOE, process characterization, process capability analysis, and root cause investigation\n\nUtilize Minitab or similar statistical software for analysis and process improvement\n\nImplement risk management and design control methodologies, including FMEA, control plans, and design transfer activities\n\nParticipate in manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and injection molding as needed\n\nWork with electro‑mechanical and capital equipment manufacturing processes if required\n\nTroubleshoot complex manufacturing and process issues and implement corrective and preventive actions\n\nRead, interpret, and create engineering drawings, including GD&T for tight‑tolerance components\n\nPerform complex statistical, geometric, and mathematical calculations\n\nOperate independently with minimal supervision on responsibilities\n\nEnsure compliance with quality systems and regulatory requirements, demonstrating commitment to patient safety and product quality\n\nPresent and defend technical positions within a collaborative environment\n\nManage multiple projects and tasks effectively\n\nWrite and review protocols, reports, specifications, and technical documentation\n\nRequirements\n\nStrong understanding of medical device manufacturing process development, transfer, optimization, and validation, specifically related to medical device capital equipment\n\nProficiency in Minitab or similar statistical software\n\nSolid foundation in statistical methods and data‑driven problem‑solving, including DOE, process characterization, process capability analysis, and root cause investigation\n\nExperience supporting complex manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, and injection molding\n\nAbility to troubleshoot complex manufacturing issues and implement effective corrective actions\n\nAbility to interpret engineering drawings and technical specifications, including GD&T\n\nStrong mathematical and statistical analysis skills\n\nExcellent project management and technical communication skills\n\nSystem One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.\n\n#J-18808-Ljbffr","company":"System One","rawCompany":"system one","city":"Waltham","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:31:38.047Z","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":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Job Title: Process Engineer\nLocation: Waltham, Massachusetts\nType: Contract\nCompensation: $45.00 - $51.00 per hour\nWork Model: Onsite\n\nJoin a leading global medical technology organization focused on life-changing healthcare innovation and high-quality manufacturing excellence. This contract opportunity is ideal for an experienced manufacturing/process engineer with expertise in medical device process development, validation, and optimization, offering hands‑on involvement with advanced capital equipment, statistical analysis, and complex catheter‑based manufacturing processes in a highly collaborative, regulated environment.\n\nResponsibilities\n\nSupport medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ), with a focus on capital equipment\n\nSupport both internally developed and externally sourced manufacturing processes within regulated environments\n\nApply statistical methods and data‑driven problem‑solving techniques, including DOE, process characterization, process capability analysis, and root cause investigation\n\nUtilize Minitab or similar statistical software for analysis and process improvement\n\nImplement risk management and design control methodologies, including FMEA, control plans, and design transfer activities\n\nParticipate in manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and injection molding as needed\n\nWork with electro‑mechanical and capital equipment manufacturing processes if required\n\nTroubleshoot complex manufacturing and process issues and implement corrective and preventive actions\n\nRead, interpret, and create engineering drawings, including GD&T for tight‑tolerance components\n\nPerform complex statistical, geometric, and mathematical calculations\n\nOperate independently with minimal supervision on responsibilities\n\nEnsure compliance with quality systems and regulatory requirements, demonstrating commitment to patient safety and product quality\n\nPresent and defend technical positions within a collaborative environment\n\nManage multiple projects and tasks effectively\n\nWrite and review protocols, reports, specifications, and technical documentation\n\nRequirements\n\nStrong understanding of medical device manufacturing process development, transfer, optimization, and validation, specifically related to medical device capital equipment\n\nProficiency in Minitab or similar statistical software\n\nSolid foundation in statistical methods and data‑driven problem‑solving, including DOE, process characterization, process capability analysis, and root cause investigation\n\nExperience supporting complex manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, and injection molding\n\nAbility to troubleshoot complex manufacturing issues and implement effective corrective actions\n\nAbility to interpret engineering drawings and technical specifications, including GD&T\n\nStrong mathematical and statistical analysis skills\n\nExcellent project management and technical communication skills\n\nSystem One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:31:38.047Z","dateModified":"2026-06-17T03:31:38.047Z","hiringOrganization":{"@type":"Organization","name":"System One","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Waltham","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"70a75b7683e7e9b1d9cbde3b"},"url":"https://jobsearcher.com/jobs/70a75b7683e7e9b1d9cbde3b"}}