Mechanical Engineer – NPD

Hello,

I hope you're doing well.

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.

• Bachelor's or Master's degree in Mechanical Engineering