Senior NPI Manufacturing Engineer

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K enrollment

Job summary

Real Staffing seeks a Senior Medical Device NPI Manufacturing Engineer for a 12-month contract in North San Jose, CA. The role focuses on manufacturing readiness, process development, and cross-functional NPI leadership to ensure smooth technology transitions.

The candidate will design and validate assembly processes, document controls, and lead lean improvements across mechanical components, fixtures, and tooling, with extensive CAD involvement.

Qualifications

• Experience in medical device NPI environments preferred.
• CAD design proficiency with SolidWorks or equivalent.
• Strong knowledge of manufacturing readiness and process validation.
• Ability to drive cross-functional reviews with R&D, Quality and Production.

Responsibilities

• Develop and maintain manufacturing readiness frameworks for product releases with 100+ components.
• Lead cross-functional NPI reviews to ensure timely product transitions.
• Create and execute NPI timelines with risk mitigation plans.

Skills

Cross-functional collaboration

Lean manufacturing

Electromechanical troubleshooting

NPI program management

Tools

SolidWorks

Job description

W2 Employment Opportunity - Unable to Offer Sponsorship

Virtual Interviews Happening This Week

Start Date: Mid September

Medical Device- Senior NPI Manufacturing Engineer

Location: North San Jose, CA

Duration: 12-Month Initial Contract - Multiyear Project, plans to extend

Role Offers: health, dental, vision benefits & 401K enrollment options

Vacation Time: 9 Paid Holidays + 13 days of accrued PTO annually

Product: Capital Equipment

New Product Introduction

• Develop and maintain comprehensive manufacturing readiness frameworks for product releases involving 100+ mechanical components
• Drive cross-functional NPI reviews with R&D, Quality, and Production teams to ensure seamless and timely product transitions
• Create and execute NPI project timelines, proactively identifying risks and implementing mitigation strategies

Manufacturing Process Development & Optimization

• Design, validate, and document assembly processes, tooling, gauges, and fixtures for precision robotic mechanisms
• Develop and maintain comprehensive documentation including design control records, product configurations, manufacturing procedures, lot history records, bills-of-materials, NPI records, LHRs, and Quality System requirements
• Apply lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
• Lead and actively participate in process/product continuous improvement projects with measurable outcomes

Electromechanical Troubleshooting & Problem Resolution

• Provide extensive electromechanical troubleshooting capabilities and instrumental expertise to rapidly resolve build issues
• Lead root cause analysis, diving deep into technical details until problems are fully understood
• Demonstrate proficiency in CAD design, rapid prototyping, tool/fixture qualification, and equipment sourcing

Targeting:

• Medical device industry experience preferred; proven track record in NPI environments highly valued
• Electromechanical Systems: Extensive troubleshooting capabilities across mechanical, electrical, and instrumentation domains
• CAD Proficiency: Expert-level skills in CAD design (SolidWorks preferred), rapid prototyping, and design for manufacturing analysis
• Manufacturing Processes: Deep knowledge of precision assembly processes, and sourcing manufacturing tools, gauges, and fixtures

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.