Senior Mechanical Engineer, Medical Device NPD (Onsite)

Intellectt INC

Dublin (CA)

On-site

USD 140,000 - 180,000

Full time

13 days ago

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Job summary

Intellectt INC in Dublin, CA is seeking an experienced Mechanical Engineer NPD to lead mechanical design and development for electromechanical medical device programs. You will drive from concept through validation, production release and design transfer in a regulated environment.

The role requires expertise in mechanical architecture, electromechanical integration, GD&T, tolerance stack‑ups, DFM/DFA, FEA, reliability, and regulatory product development, with collaboration across engineering,

Qualifications

8-12 years of mechanical design and development experience.
Significant experience in medical device new product development (NPD).
Proven experience leading electromechanical product development through the full product lifecycle in a regulated environment.
Strong proficiency with SolidWorks or Creo.

Responsibilities

Serve 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 mechanical design from concept, feasibility, and prototyping through design freeze and production release.
Translate system requirements, user needs, 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 into mechanical assemblies.
Lead and participate in dFMEA, pFMEA, and hazard analysis.
Define mechanical verification strategies and support EVT, DVT, V&V, and related testing.
Investigate and resolve failures identified during testing, manufacturing, and field feedback.
Lead DFM/DFA implementation and support manufacturing readiness.
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.
Support design changes through ECO/ECN processes.
Perform tolerance stack-ups, engineering calculations, hand calculations, and FEA.
Ensure completeness of DHF documentation and compliance with medical-device requirements.
Collaborate with Electronics, Software, Systems, Quality, Regulatory, and Supply Chain teams.
Lead design reviews, technical discussions, and customer walkthroughs.
Provide technical input for cost reduction, design optimization, and next-generation product improvements.
Mentor and technically guide junior and mid-level engineers.