Manufacturing Engineer

Manufacturing Engineer – NPI (Medical Device)We are hiring a Manufacturing Engineer with strong New Product Introduction (NPI) experience to support the successful transfer of medical device products from design to manufacturing. This role requires hands-on expertise in process development, validation, and working within regulated environments.Key ResponsibilitiesLead NPI activities including process development, equipment selection, and production readinessCollaborate with R&D, Quality, and Supply Chain teams for smooth product transferDevelop and optimize manufacturing processes, work instructions, and SOPsExecute process validations (IQ/OQ/PQ) and support equipment qualificationSupport pilot builds, engineering runs, and scale-up to full productionTroubleshoot manufacturing issues and drive continuous improvement initiativesEnsure compliance with GMP, FDA, and ISO 13485 standardsQualificationsBachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related field5–6 years of experience in medical device manufacturingStrong hands-on experience in NPI and process validationKnowledge of GMP, FDA regulations, and ISO standardsExperience in high-volume or automated manufacturing environments is preferredKey SkillsProcess development & validationProblem-solving and root cause analysisCross-functional collaborationLean Manufacturing / Six Sigma (preferred)