Mechanical Engineer

New Kensington, PA, US • Posted 7 days ago • Updated 5 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Project Development
Supervision
Test Plans
Regulatory Compliance
Research and Development
Medical Devices
Corrective And Preventive Action
Trackwise
SAP
Mechanical Engineering
Systems Design
Computer Hardware

Summary

Job Summary:

The Mechanical Project Development Engineer is responsible for designing and developing complex medical device components by translating engineering requirements into high-quality, compliant design solutions with limited supervision.
This role defines and executes test and validation activities, resolves advanced technical issues to ensure reliable production, and evaluates external components and technologies to meet quality, performance, and regulatory standards.

Roles & Responsibilities:

Designs and develops mechanical components and assemblies for medical devices by translating engineering requirements into robust, manufacturable design solutions with minimal supervision.
Troubleshoots and resolves complex mechanical and system-level issues, working cross-functionally to prevent production delays and improve product durability and reliability.
Evaluates and selects mechanical components, materials, and suppliers, ensuring designs meet performance, manufacturability, and cost objectives.
Communicates mechanical design progress and technical findings clearly, supports junior engineers, and applies mechanical engineering best practices to improve processes, product performance, and time to market.
Develops and executes mechanical test plans and validation activities to verify performance, reliability, and compliance with quality and regulatory requirements.
Support and execute Corrective and Preventive Actions (CAPA) functions within an R&D product/process scope.

Education & Experience:

Medical Device or Regulated Device experience required.
CAPA experience required.
Trackwise and SAP experience highly desired.
Bachelor's / Master's Degree in Mechanical Engineering.
minimum of 5+ years working experience with Bachelor's in areas such as Mechanical, System Design, Hardware Engineering.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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: f7b13216a8c388c488ea953db0e91078
Posted 7 days ago

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Mechanical Engineer

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Job Details

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Summary

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