Mechanical Engineer

Cincinnati, OH, US • Posted 9 days ago • Updated 9 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

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 9 days ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Mechanical Engineer

Dice Job Match Score™

Job Details

Skills

Summary

Similar Jobs