Job Title: Mechanical Project Engineer – Medical Device

Location: New Kensington, PA(Hybrid)

Job Overview

We are seeking an experienced Mechanical Project Engineer to support the design and development of complex medical device components. This role requires strong expertise in regulated environments, with a focus on delivering high-quality, compliant design solutions while ensuring product reliability and performance.

Key Requirements

• Local candidates required
• Experience in Medical Device or other regulated industries (mandatory)
• Strong experience with CAPA (Corrective and Preventive Actions)
• Experience with TrackWise and SAP (highly preferred)

Key Responsibilities

• Design and develop mechanical components and assemblies for medical devices, ensuring robust and manufacturable solutions
• Translate engineering requirements into compliant, high-quality designs with minimal supervision
• Troubleshoot and resolve complex mechanical and system-level issues to improve product performance and reliability
• Evaluate and select materials, components, and suppliers based on performance, manufacturability, and cost objectives
• Develop and execute test plans and validation activities to ensure compliance with regulatory and quality standards
• Support and execute CAPA activities within R&D and product/process scope

Qualifications

• Bachelor’s or Master’s Degree in Mechanical Engineering
• Minimum 5+ years of experience in Mechanical Design, System Design, or Hardware Engineering
• Experience working in regulated environments (medical device preferred)
• Ability to meet physical, cognitive, and environmental job requirements (with or without accommodation)