Description

You will own electrical design integrity and issue resolution for regulated medical devices.

Responsibilities

• Investigate and resolve electrical component obsolescence, supplier changes, and field issues.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Support design changes, verification/validation, and documentation updates per FDA, ISO 13485, and IEC 60601.
• Participate in risk assessments (FMEA), design reviews, and change control processes.
• Maintain technical documentation including schematics, BOMs, test protocols, and reports.

Required Skills

• 8+ years of experience in Electrical Engineering.
• Proficiency with IEC 60601 and ISO 13485 standards.
• Experience with FDA 21 CFR Part 820.
• Circuit Design and PCB Layout experience.
• Working knowledge of Embedded Systems, Matlab, and LabVIEW.
• Experience with Sensors, Drivers, and Microcontroller testing.
• Familiarity with Risk Management (FMEA) and CAPA processes.

Key Skills

Education

Bachelor's degree