Description


Responsibilities:

  • 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
  • Requirements:
  • 8 to 10 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices
  • BS in Electrical Engineering, advanced degree preferred
  • Circuit design experience to Include microprocessor, analog, digital, motion control, power supplies and battery power management
  • OrCAD Capture & Allegro PCB Designer experience strongly preferred
  • 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.

Education

Any Gradute