Senior NPI Manufacturing Engineer - Medical Device Systems

Real; San Jose (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Dental benefits

Vision benefits

401K enrollment

Job summary

Specialist Staffing Group is seeking a Medical Device Senior NPI Manufacturing Engineer in North San Jose, CA. This 12-month contract involves leading New Product Introduction activities, developing manufacturing readiness, and cross-functional collaboration with R&D, Quality, and Production to ensure timely product transitions.

The role requires extensive electromechanical troubleshooting, CAD proficiency (SolidWorks), and a strong background in lean manufacturing and design for manufacturing.

Qualifications

• 5+ years of experience in NPI for complex capital equipment.
• Experience with electromechanical troubleshooting and testing.
• Experience in pre-launch activities.
• Proficiency in CAD design with SolidWorks.
• DFM/DFX/DFX experience is valued.

Responsibilities

• Develop and maintain manufacturing readiness frameworks for product releases with 100+ mechanical components.
• Drive cross-functional NPI reviews with R&D, Quality, and Production for seamless transitions.
• Create and execute NPI project timelines with risk mitigation strategies.
• Design, validate, and document assembly processes, tooling, gauges, and fixtures for precision robotics.
• Maintain documentation including design controls, configurations, procedures, lot history, BOMs, NPI records, LHRs, and Quality System requirements.
• Apply lean manufacturing principles to reduce waste and increase productivity.
• Lead process/product continuous improvement projects with measurable outcomes.
• Provide extensive electromechanical troubleshooting to rapidly resolve build issues.
• Lead root cause analysis until problems are fully understood.
• Demonstrate CAD design, rapid prototyping, tool/fixture qualification, and equipment sourcing.

Skills

NPI

Electromechanical

CAD SolidWorks

Lean manufacturing

Root cause analysis

Tools

SolidWorks

Job description

Specialist Staffing Group is seeking a Medical Device Senior NPI Manufacturing Engineer in North San Jose, CA. This 12-month contract involves leading New Product Introduction activities, developing manufacturing readiness, and cross-functional collaboration with R&D, Quality, and Production to ensure timely product transitions.

The role requires extensive electromechanical troubleshooting, CAD proficiency (SolidWorks), and a strong background in lean manufacturing and design for manufacturing.