Introduction:
The Mechanical Project Engineer in Research and Development (R&D) is responsible for designing and developing complex medical device components, ensuring compliance with regulatory standards and quality requirements. This role involves troubleshooting mechanical issues, evaluating components and technologies, and executing test and validation activities.
Responsibilities:
- Design and develop mechanical components and assemblies for medical devices
- Troubleshoot and resolve complex mechanical and system-level issues
- Evaluate and select mechanical components, materials, and suppliers
- Communicate design progress and technical findings
- Develop and execute mechanical test plans and validation activities
- Support and execute Corrective and Preventive Actions (CAPA) functions
Requirements:
Required Skills:
- Bachelor''s / Master''s Degree in Mechanical Engineering
- 5+ years of experience in Mechanical, System Design, or Hardware Engineering
- Experience in Corrective and Preventive Action (CAPA)
- Experience in Medical Devices and Regulatory Compliance
Preferred Skills:
- Experience with Trackwise and SAP
- Experience in Project Development