Mechanical Design Engineer

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.