Mechanical Project Engineer-Medical Device

Mechanical Project Engineer-Medical Device
Address is:
Hybrid role - 3 days onsite and 2 remote. Days onsite will be 3 days between Mon - Thurs. During training, this person will need to be onsite when the engineers will be there.

Notes from the manager:
Medical Device or Regulated Device experience required.
CAPA experience required.
Trackwise and SAP experience highly desired.

Job Responsibilities:
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.

Your role:
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.

You're the right fit if:
Bachelor's / Master's Degree in Mechanical Engineering.
A 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.