No Sponsorship/Contract W2
We are seeking a skilled Senior Mechanical Design Engineer with strong expertise in medical device product development.
The ideal candidate will play a key role in design changes, maintenance releases, and ensuring regulatory compliance throughout the product lifecycle.
Must-Have Skills:
- Proven experience in implementing design changes and maintenance releases for medical device products.
- Hands-on mechanical design experience including prototyping and testing.
- Proficiency in SolidWorks or similar CAD tools for creating detailed drawings and assemblies.
- Experience maintaining and updating design history files (DHFs).
- Strong background in root cause analysis and issue resolution in medical devices.
Nice-to-Have Experience:
- Collaborating with external vendors.
- Conducting data/statistical analysis and preparing technical reports.
- Developing test procedures for verification and validation.
- Managing field complaints.
- Assessing production impacts of design changes and working cross-functionally with purchasing and production teams.
Key Responsibilities:
- Design, configure, and engineer mechanical solutions to meet customer and regulatory requirements.
- Define product components, ensure functional integration, and create detailed design documentation.
- Support manufacturing, procurement, and logistics to ensure successful implementation.
- Provide technical guidance and functional expertise across teams and projects.
Qualifications & Experience:
- 8–10 years of experience in mechanical design, preferably in the medical device industry.
- Strong problem-solving skills and ability to apply deep domain expertise across various contexts.
- Bachelor’s or Master’s degree in Mechanical Engineering or related field.