Principal Manufacturing Engineer-NPI
Job Description:POSITION SUMMARY:The Principal Engineer – NPI Manufacturing serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products.RESPONSIBILITIESThis position is responsible for, but not limited to, the following:Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables.Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes.Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards.Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production.Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes.Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC.Represent TransMedics externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers.Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation.Perform other TransMedics tasks and duties as required.PHYSICAL ATTRIBUTESOffice environmentAbility to lift up to 30 pounds MANAGEMENT RESPONSIBILITIESThis position will not have management responsibilities.MINIMUM QUALIFICATIONS BS in Mechanical Engineering or related engineering discipline required.10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.Extensive experience in NPI Manufacturing, Process Development, and Design Transfer, including both disposables and capital equipment.Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding).Proficiency in SolidWorks for 3D m...