Contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables
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
Responsible for writing electrical subsystem verification test protocols and reports
Design and develop PCBA functional test fixtures – LabView experience a plus
Prepare and execute EMC 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 and functional description documents
Prepare for and lead electrical design reviews, and contribute to system-level design reviews
Work collaboratively with external design services
Address field issues by determining root cause and implementing corrective actions as necessary
Successful track record of working in high-growth and dynamic organizations
Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components
At TransMedics, we care about people—and that includes our employees. We know our employees are key to our success and the success of our patients. We offer an engaging, supportive work environment, great benefits, and the opportunity to shape both our future and the future of transplant medicine.
TransMedics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.