Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Mechanical Engineer

Cincinnati, OH, US • Posted 30+ days ago • Updated 8 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Mechanical Engineering
  • Manufacturing Support
  • Product Optimization
  • Root Cause Analysis
  • Verification And Validation
  • Documentation
  • Collaboration
  • Issue Resolution
  • Risk Assessment
  • Design Review
  • Change Control
  • Technical Support
  • Manufacturing
  • Quality Assurance
  • Technical Writing
  • Schematics
  • Bill Of Materials
  • DMR
  • Regulatory Compliance
  • Quality Management
  • Circuit Design
  • PCB
  • Embedded Systems
  • Microcontrollers
  • Sensors
  • Electrical Engineering
  • Testing
  • MATLAB
  • LabVIEW
  • Medical Devices
  • ISO 13485
  • Risk Management
  • FMEA
  • Corrective And Preventive Action
  • Design Controls

Summary

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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 975c4d0c8077cdb88ed1644a6d4ab48d
  • Posted 30+ days ago
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