Senior Mechanical Engineer – Medical Device NPD Lead

Intellectt Inc

Dublin (CA)

On-site

USD 120,000 - 130,000

Full time

4 days ago

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Job summary

Intellectt Inc is seeking a Senior Mechanical Engineer with strong experience in medical device NPD and electromechanical product development. The engineer will provide technical leadership from concept through prototyping, verification, design freeze, and production release.

You will lead mechanical design for electromechanical devices, own architecture, enclosures, thermal management, and EMI/EMC considerations, and collaborate with cross-functional teams to ensure regulatory compliance and

Qualifications

Bachelor's or Master's in Mechanical Engineering.
8–12 years in mechanical design and development.
Experience with electromechanical integration and thermal design.
Proficient in SolidWorks or Creo.
Knowledge of GD&T, ASME Y14.5, FEA.
Experience with regulated product development (DHF, dFMEA/pFMEA).

Responsibilities

Lead development of electromechanical medical devices.
Own mechanical architecture, enclosures, mechanisms, mounts, thermal management, EMI/EMC.
Create 3D CAD models, drawings, BOMs, GD&T.
Integrate motors, sensors, PCBs, batteries, connectors, and cabling.
Lead DFM/DFA, FMEA, risk analysis, and design reviews.
Support EVT, DVT, V&V, FAI, PPAP, and design transfer.
Support ECO/ECN, NCRs, deviations, and manufacturing issue resolution.
Work with suppliers and cross-functional teams including Electrical, Software, Systems, Quality, Regulatory, and Manufacturing.
Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR 820, and IEC standards.