Lead Mechanical Design Engineer, Medical Devices

BN Associates Inc.; Dublin (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BN Associates Inc. is seeking a senior mechanical design lead in California to own the mechanical architecture of electro‑mechanical medical device programs.

You will translate system requirements into robust mechanical designs, drive end‑to‑end development, and review 3D CAD models, detailed drawings, GD&T, and BOMs. You will ensure proper integration of motors, sensors, PCBs, batteries, and connectors, while applying DFM/DFA and supporting verification and validation through

Qualifications

• 8–12 years of mechanical design experience, medical devices preferred.
• Experience leading mechanical development through full lifecycle in regulated environments.

Responsibilities

• Lead mechanical architecture and interfaces for electromechanical subsystems.
• Develop 3D CAD models, drawings, GD&T, and BOMs.
• Ensure ISO 13485, FDA 21 CFR 820, ISO 14971 compliance.
• Collaborate with cross-functional teams for DFM/DFA and manufacturing support.
• Mentor junior engineers and guide design reviews.

Skills

CAD tools

GD&T

FEM/FEA

EMI/EMC-aware

Thermal design

DFM/DFA

PLM/QMS (Windchill)

Regulated medical devices

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks or Creo

Windchill

Agile

Job description

BN Associates Inc. is seeking a senior mechanical design lead in California to own the mechanical architecture of electro‑mechanical medical device programs.

You will translate system requirements into robust mechanical designs, drive end‑to‑end development, and review 3D CAD models, detailed drawings, GD&T, and BOMs. You will ensure proper integration of motors, sensors, PCBs, batteries, and connectors, while applying DFM/DFA and supporting verification and validation through