Senior Mechanical Engineer - Sustaining Engineering
Job Title : Senior Mechanical Engineer Sustaining Engineering
Reports to : Manager Sustaining Engineering
ESSENTIAL TASKS AND DUTIES INCLUDE :
- Serve as hands-on, technical contributor in developing new products to support existing product lines with minimal oversight
- Document designs by constructing solid models, assemblies, and drawings with SolidWorks
- Fabricate prototypes utilizing internal and external resources
- Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs
- Work with internal and external manufacturing partners to ensure design for manufacturability and serviceability
- Prepare and lead design reviews, and contribute to peer design reviews
- Develop specifications, test methods, and conduct engineering feasibility testing of new and existing product designs
- Identifying and qualifying new suppliers as necessary
- Write test protocols and reports in support of product and process verification / validation
- Prepare engineering change orders and documentation
- Work cross-functionally as needed to address field issues and defects to determine root-cause and implement corrective actions as necessary
- Perform other TransMedics tasks and duties as required
BACKGROUND AND QUALIFICATIONS :
- BSME with 8 years or MSME with 6 years mechanical design / engineering experience or equivalent combination of education and experience
- Experience with FDA, ISO, and IEC standards a plus
- Proven ability to develop mechanical designs using best engineering practices
- Must have experience with applicable manufacturing processes such as injection molding, thermoforming, machining, and plastics assembly
- Experience developing and troubleshooting electromechanical systems
- Must have expertise with SolidWorks CAD software
- Full life cycle medical device development experience preferred
- Experience with analytical software packages preferred
- Must be reliable and able to work both independently and in a team environment with outstanding written and verbal communication skills
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