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 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 patients…