OVERVIEW:

TransMedics’ Sustaining Engineering team is looking for a talented Electrical Engineer to help transform organ transplantation. Reporting to the Sustaining Engineering Manager, the Senior Electrical Engineer will act as the subject matter expert and primary point of contact within the Operations group for all electrical matters. This is a critical role that drives change to on-market products, leads product improvement efforts, and supports manufacturing and NPI in design for manufacturing, assembly and test.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

• Lead electrical and contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables
• Own changes to existing PCB, electrical, and electro-mechanical assemblies for on-market products
• Responsible for designing and rapid prototyping concepts and iterating through the design process
• Ensure compliance with Design Control regulations, including, but not limited to, specification development, risk analysis, design reviews and verification and validation protocols and reports
• Work closely with product development engineering, manufacturing engineering and contract manufacturers to ensure new electrical designs are capable of being assembled and tested using modern manufacturing methods
• Prepare and execute verification and validation test plans
• Provide direct support to contract manufacturers for supply of PCB assemblies and PCB-level components
• Generate and through formal change order processes, maintain schematic, PCB, and PCBA documents
• Create written specifications, block diagrams, and functional description documents
• Prepare for and lead electrical design reviews, and contribute to system-level design reviews
• Address field issues by determining root cause and implementing corrective actions as necessary

SKILLS/REQUIREMENTS

• BSEE with 8 years of experience or MSEE with 6 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices
• Circuit design and simulation experience including microprocessor, analog, digital, motion control, power supplies, and battery & power management
• Knowledge of design for manufacturing & assembly and design for test principles
• Experience with battery design and testing preferred
• OrCAD Capture & Allegro PCB Designer experience is strongly preferred
• Experience with LabVIEW, Assembly, C/C programming a plus
• Successful track record of working in fast-paced and dynamic organizations
• Demonstrated record of curiosity, innovation, and creative problem-solving with an entrepreneurial spirit
• Must be reliable, a self-starter, and able to work independently, as well as work collaboratively
• Strong written and verbal communication skills
• Understanding of medical device development processes including experience with FDA CFR 820, IPC Standards, IEC standards and ISO 13485 regulations
• Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components