Mechanical Process Engineer

Role: Mechanical LCM Engineer(Product Lifecycle Management)

Location: Irvine, CA(Hybrid/Remote)

Duration: 12 Months(Contract#W2 only)

Client: Medical

The Mechanical LCM Engineer will support Client’s Advanced Patient Monitoring (APM) systems by improving manufacturing processes, supporting production at contract manufacturers, and driving product and process improvements. This role contributes to ongoing manufacturing, new product launches, cost reductions, and quality/compliance initiatives.

Key Responsibilities

• Identify and implement improvements to manufacturing processes using engineering tools (Six Sigma, Lean, CAD, design optimization).
• Troubleshoot and support production issues using technical principles, data analysis, and problem-solving skills.
• Lead or support manufacturing projects such as material qualifications, part and supplier changes, equipment qualifications, tolerance analyses, and product enhancements.
• Support projects such as supplier transfers, cost reduction, line extensions, and system improvements.
• Manage engineering change control, including CAD updates, process changes, product specifications, DMR updates, and test/service processes.
• Review incoming PCNs (material, mechanical, electrical changes), route them to the right owners, and maintain tracking systems.
• Monitor process metrics and drive continuous improvement.
• Develop and execute test/validation protocols for manufacturing processes; analyze data and report results.
• Resolve manufacturing and compliance issues (e.g., CAPA, non conformances, audits).
• Create training materials and work instructions for production teams.
• Build and manage project plans to ensure timely completion of deliverables.
• Perform other duties as assigned.

Education & Experience

• Bachelor’s in Engineering/Science 5 years experience
• OR
• Master’s in Engineering/Science 4 years experience
• OR
• PhD in Engineering/Science with relevant industry experience

Required Skills

• Proficient in MS Office and MS Project
• Experience with Windchill PLM (Teamcenter is a plus)
• Mechanical CAD skills (SolidWorks, CREO, ProE)
• Strong communication, documentation, and interpersonal skills
• Basic statistical knowledge
• Experience with lab/industrial equipment
• Strong problem-solving, analytical, and organizational abilities
• Understanding of engineering principles, manufacturing processes, and equipment
• Ability to lead, influence, and work cross-functionally
• Knowledge of medical device quality and safety guidelines (EHS, cleanroom practices)
• Familiarity with FDA medical device regulations preferred.

Preferred Qualifications

• Experience with medical device regulations (ISO 13485, CFR 820)
• Lean or Six Sigma certification
• Ability to read electronic schematics and mechanical drawings
• Experience troubleshooting and documenting device/subassembly/component failures.

Kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!