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.
- 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.
- 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.