Job Description
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
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