Principal Manufacturing Engineer-NPI

Job Description: RESPONSIBILITIES This position is responsible for, but not limited to, the following: Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products. 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 assigned/required. MANAGEMENT RESPONSIBILITIES This 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. PREFERRED QUALIFICATIONS Advanced degree preferred. Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design. Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding). Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling. Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred. Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones. Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams. Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders. Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities. Ability to work independently with high competency, while also driving and coordinating team-based execution. 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. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan TransMedics 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.