Principal NPI Manufacturing Engineer, Electromechanical Systems

Job Description:POSITION SUMMARYThe Principal NPI Manufacturing Engineer, Electromechanical Systems serves as the technical project leader for NPI manufacturing activities, driving the development, design transfer, manufacturing readiness, and commercialization of TransMedics OCS products.This role will have a particular focus on integrated electromechanical equipment incorporating mechanical, electrical/electronic, and software-controlled components. The Principal Engineer will provide technical leadership across new product introduction activities involving capital medical equipment, consoles, diagnostic or imaging systems, and other complex electromechanical devices while ensuring robust, scalable, compliant, and manufacturable product designs and processes.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, technical requirements, and cross-functional deliverables.Serve as a technical leader for the manufacturing introduction and commercialization of complex medical equipment incorporating mechanical, electrical/electronic, and software-controlled components.Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, Manufacturing Operations, and other engineering teams to ensure robust, scalable, and compliant manufacturing processes.Coordinate, identify, develop, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, product quality, and adherence to applicable regulatory requirements.Define project plans, timelines, technical workstreams, and resources required to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.Apply in-depth technical expertise to specify, design, develop, qualify, and validate manufacturing equipment, tooling, fixtures, automation, and manufacturing test equipment.Drive Design for Manufacturing and Assembly (DFM/DFA), PFMEA, Design Transfer, process development, and manufacturing validation activities to establish capable, efficient, and risk-mitigated manufacturing processes.Develop manufacturing assembly and functional test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.Provide manufacturing engineering expertise related to PCB/PCA assemblies, electrical and electronic components, wiring and cabling, sensors, motors and pumps, displays/HMIs, and hardware/software interfaces.Lead and support system-level troubleshooting, root-cause and failure analysis, functional testing, manufacturing test equipment development, calibration activities, and hardware reliability assessments during new product introduction and manufacturing scale-up.Develop and optimize manufacturing processes for integrated electromechanical assemblies, subassemblies, and final system-level builds.Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools and methodologies such as MSA, GR&R, SPC, and related process capability techniques.Represent TransMedics internally and externally as a manufacturing subject matter expert (SME), ensuring effective technical communication and knowledge transfer to production teams, suppliers, and cross-functional stakeholders.Provide day-to-day technical leadership and direction across assigned NPI workstreams.Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, problem solving, and innovation.Perform other TransMedics tasks and duties as required.PHYSICAL ATTRIBUTESOffice and manufacturing environment.Ability to lift up to 30 pounds.MANAGEMENT RESPONSIBILITIESThis position will not have direct people-management responsibilities.The position will provide technical leadership, mentoring, and workstream direction to engineers and other technical team members supporting assigned NPI programs.MINIMUM QUALIFICATIONSBS in Mechanical Engineering, Electrical Engineering, Electromechanical Engineering, Mechatronics, Biomedical Engineering, or a related engineering discipline required.10+ years of progressive engineering experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.Extensive experience in NPI Manufacturing, Process Development, Design Transfer, DFM/DFA, PFMEA, manufacturing validation, and commercialization of medical devices or medical equipment.Direct experience supporting the development and manufacturing introduction of capital medical equipment, consoles, diagnostic systems, imaging systems, robotics, or similar integrated electromechanical devices.Demonstrated experience working with complex systems incorporating mechanical, electrical/electronic, and software-controlled components.Hands-on experience with PCB/PCA assemblies, electrical/electronic components, wiring and cabling, sensors, motors/pumps, displays/HMIs, and hardware/software interfaces.Demonstrated experience with system-level troubleshooting, root-cause and failure analysis, functional testing, manufacturing test equipment, calibration, and hardware reliability.Proven leadership in the selection, qualification, implementation, and scale-up of manufacturing equipment, tooling, fixtures, and automation.Demonstrated ability to lead complex technical NPI projects from product development through design transfer, manufacturing scale-up, and commercial production.Strong project leadership skills, with demonstrated accountability for technical planning, execution, cross-functional coordination, and delivery of NPI milestones.Ability to remain technically hands-on while simultaneously providing strategic direction and leadership across complex engineering workstreams.PREFERRED QUALIFICATIONSAdvanced degree in an engineering or related technical discipline.Knowledge of or experience with IEC 60601 requirements applicable to medical electrical equipment.Proficiency in SolidWorks or similar 3D CAD software for the review or development of assembly models, fixtures, tooling, and manufacturing concepts.Lean Six Sigma experience and proficiency in statistical data analysis tools such as Minitab or equivalent.As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.Every Organ Wasted is a Life Not Saved.TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.Maximize your potential at TransMedics, Inc.TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $147,200.00-$183,600.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.Employee Benefit:Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVisionHealthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insuranceEmployee Stock Purchase PlanTransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr Jobleads-US