Mechanical Engineer

Katalyst Healthcares & Life Sciences • Cincinnati, OH, US • 5h ago

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.

Roles & Responsibilities:

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:

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

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