Principal Manufacturing Engineer

Job DescriptionJob DescriptionPURPOSE OF JOBWe are seeking a skilled Medical Device Manufacturing Engineer to join our manufacturing team. This role is responsible for designing and optimizing manufacturing processes, creating comprehensive documentation, and sustaining production lines for medical devices in a regulated environment. The ideal candidate will have experience in fixture design, process optimization, and working within FDA/ISO quality standards.MAJOR DUTIES AND RESPONSIBILITIESManufacturing Line SustainingProvide ongoing technical support for production lines to ensure consistent output and qualityInvestigate and resolve manufacturing deviations, non-conformances, and customer complaintsSupport production scale-up activities and technology transfersTrain production personnel on new processes and equipmentCoordinate with cross-functional teams including Quality, Regulatory, and R&DFixture Design & ToolingDesign, develop, and validate manufacturing fixtures, jigs, and tooling for medical device assembly and testing processesCreate detailed engineering drawings and specifications using CAD softwareCollaborate with machining vendors and internal teams to ensure fixtures meet design requirements and delivery timelinesPerform fixture qualification studies and document results per regulatory requirementsManufacturing Process OptimizationAnalyze existing manufacturing processes to identify opportunities for improvement in efficiency, quality, and cost reductionImplement lean manufacturing principles and continuous improvement methodologiesConduct time studies, capability analyses, and statistical process control initiativesDesign and execute process validation protocols (IQ/OQ/PQ) for new and modified processesTroubleshoot production issues and implement corrective and preventive actionsManufacturing DocumentationDevelop and maintain manufacturing procedures, work instructions, and process specificationsCreate and update manufacturing drawings, assembly procedures, and quality control documentationEnsure all documentation complies with FDA regulations, ISO 13485, and company quality standardsMaintain accurate revision control and document management systemsEDUCATION REQUIREMENTSBS or MS in Engineering or related discipline or equivalent experience in the medical device industryEXPERIENCE REQUIREMENTS3-5 years of experience working on FDA Class II or Class III medical device manufacturing or regulated manufacturing environmentProficiency in CAD software (SolidWorks, AutoCAD, or similar)Strong understanding of manufacturing processes including machining, injection molding, assembly, and testingKnowledge of FDA regulations (21 CFR Part 820) and ISO 13485 quality management systemsExperience with statistical analysis tools and process validation methodologiesExperience working on Injection molding or inserting molding (Desired)Experience working on electro-mechanical medical devicesStrong problem-solving skills and attention to detailExcellent written and verbal communication skillsExperience in manufacturing and controlling sterile productREQUIRED SKILLS/ ABILITIESKnowledge of and experience in pilot/production line set-up and validation in Controlled EnvironmentsExperience working under quality system designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDR, and knowledge of relevant standardsAbility to detail project plans effectivelyFamiliar with developing Master Validation Plans & executing operational and performance validationsFamiliar of GMP, GDP procedures and requirementsFamiliar with Design Control procedures and requirementsExcellent verbal and written communication skills are requiredExperience working to environmental health and safety regulationsProject management experience #J-18808-Ljbffr

Created: 2025-09-17