Mechanical Engineer- NPD

Job Role: Mechanical Engineer- NPD 
Job Location: Dublin, CA
Remote/Onsite: Onsite
Benefits: Medical,Dental,Vision, 4O1Kplan, PTO
Job Type:Full Time/Contract
Duration: Long term Project
No. of positions: 01
Hiring Timeline: 2,3 weeks

Job Description & Skill Requirement:

Technical Leadership & System Ownership

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own the mechanical architecture and interfaces for electro‑mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
• Lead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to 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.
• Ensure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
• Execute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.
• Ensure completeness and quality of Design History File (DHF) documentation.
• Lead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.
• Support design changes through formal ECO/ECN processes.
• Define mechanical verification strategies and support DVT, EVT, and V&V testing.
• Investigate and resolve failures observed during testing, manufacturing, or field feedback.
• Lead application of DFM/DFA principles for manufacturing processes.
• Work closely 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 related to mechanical design.
• Collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.
• Lead and participate in design reviews, technical discussions, and customer walkthroughs.
• Guide and 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

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