{"schemaVersion":"jobsearcher.job.v1","id":"3fd958051c2c668010b7f121","url":"https://jobsearcher.com/jobs/3fd958051c2c668010b7f121","canonicalUrl":"https://jobsearcher.com/jobs/3fd958051c2c668010b7f121","title":"Process Development Engineer","description":"Job Summary\nWe are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational excellence.\n\nResponsibilities\n\nLead process development and industrialization activities for new product introductions (NPI), product enhancements, and manufacturing transfers.\n\nCollaborate with R&D and Product Development teams during concept, feasibility, design verification, and design transfer phases to ensure manufacturable product designs.\n\nPerform comprehensive DFMA (Design for Manufacturing & Assembly) assessments to optimize product architecture, assembly methods, cost, quality, and throughput.\n\nConduct CAD-based Assembly Tolerance Requirement (ATR) analyses and tolerance stack-up evaluations to validate assembly robustness and product performance requirements.\n\nDevelop manufacturing process strategies, assembly methodologies, tooling concepts, fixtures, and automation solutions to support scalable production.\n\nDefine and establish Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs) to ensure process capability, product quality, and manufacturing consistency.\n\nDesign, execute, and analyze process characterization studies, DOE (Design of Experiments), capability assessments, and process validation activities.\n\nLead Process Failure Mode and Effects Analysis (pFMEA) activities and implement effective risk mitigation plans throughout product lifecycle development.\n\nDevelop manufacturing standards, best practices, and structured DFMA review processes to support stage-gate product development activities.\n\nEvaluate and improve existing manufacturing and assembly processes through Lean Manufacturing, Six Sigma, and continuous improvement methodologies.\n\nSupport equipment selection, process qualification, process validation, and vertical start-up activities for new manufacturing lines.\n\nEstablish process controls, monitoring strategies, and statistical methods to maintain long-term manufacturing performance.\n\nReview and modify detailed CAD models and engineering drawings to ensure compliance with manufacturing, assembly, tolerance, and quality requirements.\n\nRequirements\n\nBachelor's Degree with 10+ years of experience, or Master's Degree with 8+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or other highly regulated industries.\n\nExtensive experience supporting New Product Development (NPD) and product commercialization activities.\n\nStrong expertise in Design for Manufacturing and Assembly (DFMA) methodologies.\n\nHands‑on experience performing Assembly Tolerance Analysis (ATR) and tolerance stack‑up assessments.\n\nAdvanced proficiency with CAD and SolidWorks for product and assembly development.\n\nExperience developing manufacturing processes, assembly systems, fixtures, tooling, and automation solutions.\n\nStrong knowledge of DFSS, DOE, Statistical Process Control (SPC), Process Capability Analysis, and Process Validation methodologies.\n\nExperience leading pFMEA, risk assessments, and process optimization initiatives.\n\nDemonstrated ability to work cross‑functionally with R&D, Quality, Operations, Supply Chain, and Manufacturing teams.\n\nExperience within FDA-regulated, ISO 13485, or similarly regulated manufacturing environments preferred.\n\nPreferred Qualifications\n\nMedical device manufacturing experience.\n\nAutomated assembly and high‑volume manufacturing experience.\n\nLean Manufacturing and Six Sigma certification.\n\nTechnology transfer and global manufacturing support experience.\n\nStrong technical leadership, mentoring, and project management skills.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Covington","state":"GA","isRemote":false,"isActive":true,"createdAt":"2026-06-17T04:11:43.708Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-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":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer","description":"Job Summary\nWe are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational excellence.\n\nResponsibilities\n\nLead process development and industrialization activities for new product introductions (NPI), product enhancements, and manufacturing transfers.\n\nCollaborate with R&D and Product Development teams during concept, feasibility, design verification, and design transfer phases to ensure manufacturable product designs.\n\nPerform comprehensive DFMA (Design for Manufacturing & Assembly) assessments to optimize product architecture, assembly methods, cost, quality, and throughput.\n\nConduct CAD-based Assembly Tolerance Requirement (ATR) analyses and tolerance stack-up evaluations to validate assembly robustness and product performance requirements.\n\nDevelop manufacturing process strategies, assembly methodologies, tooling concepts, fixtures, and automation solutions to support scalable production.\n\nDefine and establish Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs) to ensure process capability, product quality, and manufacturing consistency.\n\nDesign, execute, and analyze process characterization studies, DOE (Design of Experiments), capability assessments, and process validation activities.\n\nLead Process Failure Mode and Effects Analysis (pFMEA) activities and implement effective risk mitigation plans throughout product lifecycle development.\n\nDevelop manufacturing standards, best practices, and structured DFMA review processes to support stage-gate product development activities.\n\nEvaluate and improve existing manufacturing and assembly processes through Lean Manufacturing, Six Sigma, and continuous improvement methodologies.\n\nSupport equipment selection, process qualification, process validation, and vertical start-up activities for new manufacturing lines.\n\nEstablish process controls, monitoring strategies, and statistical methods to maintain long-term manufacturing performance.\n\nReview and modify detailed CAD models and engineering drawings to ensure compliance with manufacturing, assembly, tolerance, and quality requirements.\n\nRequirements\n\nBachelor's Degree with 10+ years of experience, or Master's Degree with 8+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or other highly regulated industries.\n\nExtensive experience supporting New Product Development (NPD) and product commercialization activities.\n\nStrong expertise in Design for Manufacturing and Assembly (DFMA) methodologies.\n\nHands‑on experience performing Assembly Tolerance Analysis (ATR) and tolerance stack‑up assessments.\n\nAdvanced proficiency with CAD and SolidWorks for product and assembly development.\n\nExperience developing manufacturing processes, assembly systems, fixtures, tooling, and automation solutions.\n\nStrong knowledge of DFSS, DOE, Statistical Process Control (SPC), Process Capability Analysis, and Process Validation methodologies.\n\nExperience leading pFMEA, risk assessments, and process optimization initiatives.\n\nDemonstrated ability to work cross‑functionally with R&D, Quality, Operations, Supply Chain, and Manufacturing teams.\n\nExperience within FDA-regulated, ISO 13485, or similarly regulated manufacturing environments preferred.\n\nPreferred Qualifications\n\nMedical device manufacturing experience.\n\nAutomated assembly and high‑volume manufacturing experience.\n\nLean Manufacturing and Six Sigma certification.\n\nTechnology transfer and global manufacturing support experience.\n\nStrong technical leadership, mentoring, and project management skills.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:11:43.708Z","dateModified":"2026-06-17T04:11:43.708Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Covington","addressRegion":"GA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3fd958051c2c668010b7f121"},"url":"https://jobsearcher.com/jobs/3fd958051c2c668010b7f121"}}