Position Overview:
We are seeking a Senior Electrical Engineer to join our on-site Engineering team supporting our Neonatal Care product line. This individual will play a critical role in sustaining engineering efforts for life-saving medical devices such as incubators, infant warmers, jaundice testing equipment, and blue light therapy systems. This is a reactive, hands-on role focused on troubleshooting and maintaining existing products in the field - not new product development (at this time).
You will be 1 of 2 electrical engineers tasked with diagnosing technical issues, evaluating and documenting component changes, supporting deviation requests, and ensuring continued regulatory compliance. Collaboration with cross-functional partners in Quality, Regulatory, and Mechanical Engineering will be essential.
Key Responsibilities:
- Provide day-to-day electrical engineering support for existing neonatal medical devices.
- Perform root cause analysis and troubleshooting of analog and digital circuitry.
- Document engineering assessments, justifications for component substitutions, and support deviation requests.
- Design and implement circuit modifications related to component obsolescence or performance improvements.
- Collaborate with Quality, Mechanical, and Regulatory teams to maintain compliance with medical device standards.
- Support EMI, EMC, and ESD analysis and mitigation strategies.
- Utilize integrated development tools such as CAD, Mentor Graphics, or Cadence for design and documentation.
- Participate in internal audits and support documentation for regulatory submissions as needed.
Must-Have Qualifications:
- Bachelor's degree in Electrical Engineering (required)
- 5+ years of experience in a regulated industry (e.g., Medical Devices, Aerospace)
- Strong experience in both analog and digital circuit design and troubleshooting
- Proficiency in Integrated Development Environments (Mentor, Cadence, or similar CAD tools)
- Hands-on experience with EMI/EMC/ESD testing and shielding strategies
- Proven ability to work independently while effectively collaborating with cross-functional teams
Preferred Qualifications:
- Master's degree in Electrical Engineering
- Prior experience in medical device development or sustaining engineering
- Experience in the full product lifecycle, including new product development and sustaining support
- Familiarity with neonatal care devices and FDA regulations
