Principal Manufacturing Engineer-NPI

TransMedics, Inc. • Andover, MA

101d

About The Position

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.

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.
• Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.

Nice To Haves

• 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.
• Proficiency in SolidWorks for 3D modeling and design.
• Lean Six Sigma experience and proficiency in statistical data analysis tools.
• Strong project management skills.
• Exceptional leadership and interpersonal skills.
• Excellent verbal and written communication skills.
• Proven ability to thrive in a fast-paced, dynamic environment.

Responsibilities

• Serve as the technical project leader for NPI manufacturing activities.
• Provide strategic oversight of manufacturing readiness for new product introductions.
• Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations.
• Coordinate, identify, and implement advanced manufacturing processes.
• Define project plans, timelines, and resources needed to support NPI manufacturing programs.
• Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation.
• Drive PFMEA, DFM/DFA, and design transfer activities.
• Develop manufacturing assembly and test methods that ensure CTQ and CTA requirements are met.
• Establish and track Key Performance Indicators (KPIs) and process capability metrics.
• Represent TransMedics as a manufacturing subject matter expert (SME).
• Mentor and guide junior engineers and technical staff.
• Perform other TransMedics tasks and duties as assigned/required.

Benefits

• 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

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees