Lead Electromechanical Engineer – Medical Device Systems

Purple Hires Inc; Dublin (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Purple Hires Inc. is seeking an experienced Mechanical Engineer for our Dublin, CA onsite team.

You will lead mechanical design for electromechanical medical device programs, owning architecture, interfaces, and DSF through production release, while ensuring ISO 13485, FDA 21 CFR 820, and other standards compliance. You will collaborate with electronics, software, systems, quality, regulatory, and supply chain teams, guide junior engineers, and drive cost reduction and design optimization

Qualifications

• Bachelor's or Master's in Mechanical Engineering.
• 8–12 years in mechanical design, medical devices preferred.
• Experience leading mechanical development of electromechanical products in regulated environments.

Responsibilities

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own mechanical architecture and interfaces for subsystems including enclosures, mechanisms, mounts, thermal paths, EMI/EMC considerations.
• Lead end-to-end mechanical design from concept to production release.
• Translate user needs and constraints into robust mechanical designs.
• Develop and review 3D CAD models, drawings, GD&T, and BOMs.
• Ensure integration of motors, sensors, PCBs, batteries, connectors, and cabling.
• Comply with ISO 13485, FDA 21 CFR 820, ISO 14971, IEC standards; maintain DHF.
• Lead risk management (dfMEA, pfMEA, hazard analysis).
• Support ECO/ECN processes and design changes.
• Define verification strategies and support DVT/EVT/V&V testing.
• Investigate failures and drive corrective actions.
• Apply DFM/ DFA for manufacturability and work with suppliers.

Skills

SolidWorks

Creo

Materials knowledge

Electromechanical design

GD&T

DFM/DFT

FEA

Windchill

Agile

Education

Bachelor's or Master's degree in Mechanical Engineering

Tools

Windchill

Agile

Job description

Purple Hires Inc. is seeking an experienced Mechanical Engineer for our Dublin, CA onsite team.

You will lead mechanical design for electromechanical medical device programs, owning architecture, interfaces, and DSF through production release, while ensuring ISO 13485, FDA 21 CFR 820, and other standards compliance. You will collaborate with electronics, software, systems, quality, regulatory, and supply chain teams, guide junior engineers, and drive cost reduction and design optimization