Senior NPI Manufacturing Engineer

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

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

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

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

Desired Skills and Experience

Targeting

• -5+ years of experience
• -Prior work experience with complex capital equipment
• -Electromechanical testing and troubleshooting
• -DFM/DFA/DFX
• -Experience in pre-launch activities

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.