We are seeking a talented and detail-oriented Electronics Engineer to design, develop, and validate electronic systems for medical devices. The ideal candidate will have robust analog, digital and embedded circuit design experience, an understanding of regulatory requirements (FDA, ISO 13485), and experience working through full product development lifecycles—from concept to production.
This role requires close collaboration with cross-functional teams including mechanical engineering, software, quality, regulatory, and manufacturing.
Key Responsibilities
Design and develop analog and digital circuits for medical devices, including sensor interfaces, power management, digital controls, and communication systems.
Perform schematic capture, PCB layout, and prototype bring-up.
Conduct circuit simulations, tolerance analysis, and design verification testing.
Support EMI/EMC design and pre‑compliance testing.
Develop and execute verification and validation (V&V;) test protocols.
Contribute to design reviews and technical documentation.
Ensure designs comply with applicable standards (e.g., IEC 60601).
Support regulatory submissions and audits as required.
Collaborate with manufacturing teams for DFM/DFT optimization.
Support product transfer to manufacturing and production troubleshooting.
Investigate field issues and implement corrective actions.
Required Qualifications
Bachelor’s degree in Electrical Engineering or related field (Master’s preferred).
4+ years of experience in electronics design.
Strong experience in:
Analog and digital circuit design
Embedded systems and microcontrollers.
Oscilloscopes, logic analyzers, and lab instrumentation
Understanding of power electronics and low‑noise design.
Experience with regulatory settings.
Solid documentation and communication skills.
Preferred Qualifications
Experience in medical device industry
Experience with battery‑powered and portable devices.
Familiarity with signal processing for biomedical sensors.
Experience with design controls ( (FDA, ISO 13485).
Experience supporting clinical or pilot manufacturing builds.
J-18808-Ljbffr