Principal Manufacturing Engineer-NPI

Principal Engineer – NPI Manufacturing

The Principal Engineer – NPI Manufacturing serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of Trans Medics 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 Trans Medics 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 Trans Medics tasks and duties as required.

• Office environment
• Ability to lift up to 30 pounds

• This position will not have management responsibilities.

• 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 Solid Works for 3D modeling and design of assembly models, fixtures, and tooling.

• Advanced degree
• 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.
• Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design.

As part of our long-term growth plans, Trans Medics 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.

Trans Medics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for…