Principal Engineer – NPI Manufacturing at TransMedics

Compensation

$147,200 – $183,600/yr

Setup: Hybrid
Location: Andover, Massachusetts
Type: Full-time
Level: Principal

Description

The Principal Engineer - NPI Manufacturing leads the technical project for developing and commercializing TransMedics perfusion sets and OCS products. Responsibilities include overseeing manufacturing readiness, leading cross-functional collaborations, implementing advanced manufacturing processes, defining project plans, applying technical expertise for equipment specification, driving PFMEA and design transfer activities, establishing KPI tracking, acting as a manufacturing SME, and mentoring junior engineers.

Required Skills

Mechanical Engineering
FDA/ISO-regulated medical device manufacturing
NPI Manufacturing
Process Development
Design Transfer
capital assembly equipment
automation
injection molding
plastic joining techniques
SolidWorks

Additional Information

Minimum Education: BS in Mechanical Engineering or related engineering discipline
Required Previous Experiences: 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
Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent)
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.

About TransMedics

TransMedics

medical devicesAndover, MA501-1000

TransMedics provides end-to-end technology & expert clinical service solutions that maximize heart & lung transplant volume, clinical outcomes and reduce learning curves.

Open roles: 33
Founded: 1998

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