Principal Manufacturing Engineer-NPI

TransMedics, Inc.•Andover, MA

2d•$147,200 - $183,600•Onsite

About The Position

The Principal Engineer – NPI Manufacturing serves as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products. This position is responsible for providing strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables. It involves leading cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes. The role also includes coordinating, identifying, and implementing advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards. Defining project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables, is also a key responsibility. The Principal Engineer will apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production. Driving PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes, as well as developing manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met, are crucial. Establishing and tracking Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC, and representing TransMedics externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers, are also part of the role. Additionally, the position involves mentoring and guiding junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation. The role may also include other TransMedics tasks and duties as required.

Requirements

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 modeling and design of assembly models, fixtures, and tooling.

Nice To Haves

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.

Responsibilities

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.