Mechanical Engineer

Job Summary:

• The Electro-Mechanical Engineer will lead electrical engineering activities for sustaining and legacy medical device products. This role focuses on resolving component obsolescence, supplier changes, and field issues while ensuring compliance with FDA, ISO 13485, and IEC 60601 standards.
• The engineer will collaborate cross-functionally to support design changes, risk management, manufacturing support, and continuous product improvement.

• Lead electrical engineering activities for sustaining and legacy medical device products
• 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 and validation activities, and documentation updates in compliance with regulatory standards
• Collaborate with cross-functional teams to ensure timely issue resolution and design improvements
• Participate in risk assessments (FMEA), design reviews, and change control processes
• Provide technical support to manufacturing, test engineering, and quality assurance teams
• Maintain and update technical documentation including schematics, BOMs, test protocols, DHF, DMR, and reports
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and internal quality systems

• Experience with circuit design, PCB layout, and embedded systems
• Hands-on experience with microcontrollers, sensors, drivers, and electrical testing
• Knowledge of MATLAB and LabVIEW
• Strong understanding of medical device regulations and standards including IEC 60601, ISO 13485, and FDA 21 CFR Part 820
• Experience with risk management (FMEA), CAPA, sustenance engineering, and design control