About the Role
We are looking for a skilled Design Engineer to join our team and contribute to medical device product design and development. This role involves design control, risk management, and documentation compliance to meet global regulatory standards.
Key Responsibilities
- Design and develop mechanical components for medical devices
- Ensure compliance with medical device design control and regulatory requirements
- Manage design changes, documentation, and risk analysis
- Perform DFMEA and support DHF/DMR remediation
- Collaborate with cross-functional teams for product lifecycle management
- Utilize PLM tools like Windchill for design documentation
- Prepare detailed CAD models and drawings using SolidWorks
- Apply GD&T principles for accurate design specifications
Required Skills & Qualifications
- Bachelor's or Master's degree in Mechanical Engineering
- Hands-on experience in medical device design control
- Proficiency in SolidWorks, GD&T, and PLM tools (Windchill or equivalent)
- Strong knowledge of risk management and DFMEA
- Excellent written and verbal communication skills
- Preferred: Experience in medical device industry
