Principal Mechanical Engineer - Sustaining Engineer

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

TransMedics is seeking a Principal Mechanical Engineer to serve as a technical lead across our on-market product portfolio. In this role, you will drive innovation, mentor engineering teams, and lead the end-to-end development of complex mechanical designs — setting standards that elevate the entire organization. This position is responsible for, but not limited to, the following: Serve as the technical lead in developing new designs for on-market product lines, operating with full autonomy and influencing organizational engineering direction. Prepare, own, and chair design reviews at the program level while contributing to cross-functional design reviews as a subject matter expert. Lead and produce advanced SolidWorks solid models, assemblies, and engineering drawings. Lead structural, dimensional, fluid, vibration, thermal, and reliability analyses for new and existing products. Oversee prototype fabrication strategy utilizing internal and external resources. Define and own product and process specifications, test methodologies, and engineering feasibility frameworks for new and existing product lines. Author and execute V&V test protocols and technical reports ensuring compliance with regulatory and quality system requirements. Own engineering change orders and technical documentation at the system level, ensuring traceability and alignment with design history requirements. Collaborate with internal and external manufacturing partners at a strategic level to ensure design for manufacturability across the product portfolio. Identify, evaluate, and qualify strategic suppliers to support program and technology roadmaps. Lead cross-functional investigations into field issues and product defects driving systematic root-cause analysis and implement robust, scalable corrective actions. Perform other TransMedics tasks and duties as assigned/required.

Requirements

BSME with 10 years or MSME with 8 years mechanical design/engineering experience or equivalent combination of education and experience
Proven ability to develop mechanical designs using best engineering practices
Must have experience with applicable manufacturing processes such as injection molding, thermoforming, machining, and plastic joining technologies.
Experience developing and troubleshooting electromechanical systems
Must have expertise with SolidWorks CAD software
Must be reliable and able to work both independently and in a team environment with outstanding written and verbal communication skills

Nice To Haves

Experience with FDA, ISO, and IEC standards
Full life cycle medical device development experience preferred
Experience with analytical software packages preferred

Responsibilities

Serve as the technical lead in developing new designs for on-market product lines, operating with full autonomy and influencing organizational engineering direction.
Prepare, own, and chair design reviews at the program level while contributing to cross-functional design reviews as a subject matter expert.
Lead and produce advanced SolidWorks solid models, assemblies, and engineering drawings.
Lead structural, dimensional, fluid, vibration, thermal, and reliability analyses for new and existing products.
Oversee prototype fabrication strategy utilizing internal and external resources.
Define and own product and process specifications, test methodologies, and engineering feasibility frameworks for new and existing product lines.
Author and execute V&V test protocols and technical reports ensuring compliance with regulatory and quality system requirements.
Own engineering change orders and technical documentation at the system level, ensuring traceability and alignment with design history requirements.
Collaborate with internal and external manufacturing partners at a strategic level to ensure design for manufacturability across the product portfolio.
Identify, evaluate, and qualify strategic suppliers to support program and technology roadmaps.
Lead cross-functional investigations into field issues and product defects driving systematic root-cause analysis and implement robust, scalable corrective actions.
Perform other TransMedics tasks and duties as assigned/required.