Electro Mechanical Engineer

Soho Square Solutions; Irvine (CA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Soho Square Solutions in Irvine, CA is seeking a Mechanical Engineer III (Electro-Mechanical) to support lifecycle management of electro-mechanical medical devices. You will collaborate with sustaining engineering, contract manufacturing, and product transfer initiatives to ensure robust design and manufacturing processes.

The role emphasizes hands-on problem solving, change control, protocol development, and cross-functional communication to deliver safe, compliant devices on schedule in a

Qualifications

• BS in Engineering with 5+ years of relevant experience (or MS with 4+, or PhD).
• SolidWorks, Creo or Pro/ENGINEER and Windchill PLM experience.
• Ability to read electronic schematics and mechanical drawings.
• Working knowledge of statistics and manufacturing process controls.
• Strong technical writing and MS Project proficiency.

Responsibilities

• Support production at a contract manufacturer through problem solving and data analysis.
• Manage change control, including CAD updates, change requests, DMR, and product specifications.
• Write and execute protocols to qualify and validate manufacturing processes.
• Resolve CAPAs, non-conformances, and audit observations.
• Build work instructions and training materials for production.

Skills

Read schematics

Mechanical drawings

Statistical methods

Technical writing

Education

BS in Engineering with 5+ years experience

Tools

SolidWorks

Creo

Pro/ENGINEER

Windchill PLM

MS Project

Job description

Mechanical Engineer III (Electro-Mechanical) | Medical Devices | Irvine, CA (Hybrid)

We're hiring a Mechanical Engineer III to support a medical device manufacturer on lifecycle management for electro-mechanical systems. You'll work across sustaining engineering, contract manufacturing support, and product transfer projects.

What you'll do

• Support production at a contract manufacturer through problem solving and data analysis
• Manage change control, including CAD updates, change requests, DMR, and product specifications
• Write and execute protocols to qualify and validate manufacturing processes
• Resolve CAPAs, non-conformances, and audit observations
• Build work instructions and training materials for production

What you bring

• BS in Engineering with 5+ years of relevant experience (or MS with 4+, or PhD)
• SolidWorks, Creo, or Pro/ENGINEER
• Windchill PLM
• Ability to read electronic schematics and mechanical drawings
• Working knowledge of statistical methods and manufacturing process controls
• Microsoft Project and strong technical writing

Nice to have

• ISO 13485 and 21 CFR Part 820 experience
• Lean or Six Sigma certification
• Teamcenter PLM
• Clean-room manufacturing experience
• Failure analysis on finished devices, subassemblies, and components

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