Mechanical Engineer - NPD

Hi,

Hope you are doing good,

My name is Ayaan, and I'm a Senior Recruiter at Intellectt Inc. I came across your profile and believe your experience could be a good match for an exciting opportunity I'm currently working on

If you're interested, please send your updated resume to View email address on us.fitly.work

Job Title: Mechanical Engineer NPD
Durations: Long-Term
Location: Dublin, CA

Job Description & Skill Requirement
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.

Experience
8 12 years of Mechanical Design & Development experience.
Significant experience in Medical Device NPD.
Proven experience leading electromechanical product development through the full product lifecycle in regulated environments.

Required Technical Skills
SolidWorks or Creo
Medical device materials & manufacturing processes
Electromechanical integration
Thermal considerations
EMI/EMC-aware mechanical design
Reliability engineering
GD&T ASME Y14.5
Tolerance Stack-up
DFM/DFA
FEA & Engineering Calculations
PLM/QMS Windchill, Agile

Priority 1 Must Have
8 12 years Mechanical Design & NPD
Medical Device industry experience
SolidWorks or Creo
Mechanical architecture & electromechanical integration
GD&T + ASME Y14.5 + Tolerance Stack-up
DFM / DFA
FEA & engineering calculations
ISO 13485 / FDA 21 CFR 820
ISO 14971, FMEA, DHF
EVT/DVT, V&V, design transfer

Priority 2 Preferred
Windchill / Agile PLM/QMS
EMI/EMC-aware mechanical design
Thermal management
ECO/ECN
Supplier / CM management
FAI / PPAP / pilot builds
NCR / deviation handling
Design reviews & cross-functional leadership

Education & Experience
Bachelor's/Master's in Mechanical Engineering
8 12 years mechanical design/development
Strong medical-device NPD experience