My name is Rudra, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Mechanical Engineer NPD based in Dublin, CA with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at prasad.kunnath@intellectt.com
Job Title: Mechanical Engineer NPD Location: Dublin, CA Work Arrangement: Onsite Experience Level: 8-12 years
Job Description Technical Leadership & System Ownership
Act as Technical Lead for Mechanical Design within electromechanical medical device programs.
Own mechanical architecture and interfaces for enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
Lead end-to-end mechanical design from concept, feasibility, and prototyping through design freeze and production release.
Translate user needs, system requirements, and electrical/software constraints into robust mechanical designs.
Develop and review 3D CAD models, detailed drawings, GD&T, and BOMs.
Integrate motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
Ensure compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.
Ensure completeness of Design History File (DHF) documentation.
Lead and participate in dFMEA, pFMEA, and hazard analysis.
Support design changes through ECO/ECN processes.
Define mechanical verification strategies and support DVT, EVT, and V&V testing.
Investigate and resolve failures during testing, manufacturing, and field feedback.
Lead DFM/DFA implementation.
Work with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.
Support FAI, PPAP, pilot builds, and design transfer to manufacturing.
Drive resolution of manufacturing issues, NCRs, and deviations.
Collaborate with Electronics, Software, Systems, Quality, Regulatory, and Supply Chain teams.
Lead design reviews, technical discussions, and customer walkthroughs.
Perform engineering analyses including tolerance stack-ups, hand calculations, and FEA.
Provide technical input for cost reduction, design optimization, and next-generation improvements.
Mentor and technically guide junior and mid-level engineers.
Qualification
Bachelor's or Master's degree in Mechanical Engineering