NPI Manufacturing Engineer- Medical Device- North San Jose

Real; San Jose (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health benefits

Dental benefits

Vision benefits

401K enrollment

Job summary

Specialist Staffing Group seeks a Medical Device NPI Manufacturing Engineer for a multiyear contract in North San Jose, CA. The role focuses on creating and maintaining manufacturing readiness for complex product releases and coordinating with R&D, Quality, and Production to ensure smooth transitions.

Responsibilities include designing assembly processes, validating tooling, and documenting procedures with design controls while applying lean methods to boost productivity.

Qualifications

• Medical device NPI experience preferred.
• 4+ years in electromechanical manufacturing roles.
• SolidWorks and rapid prototyping experience.
• Ability to create and maintain design control records.

Responsibilities

• Develop and maintain manufacturing readiness frameworks for product releases with 100+ components.
• Drive cross-functional NPI reviews with R&D, Quality, and Production to ensure seamless transitions.
• Create and execute NPI project timelines with risk mitigation strategies.
• Lead production process design, validation, and documentation including LHRs and BOMs.

Skills

Electromechanical

CAD design

Root cause analysis

Lean manufacturing

Education

B.S. in Engineering

Tools

SolidWorks

Rapid prototyping

Job description

W2 Employment Opportunity - Unable to Offer Sponsorhsip

Interviews: Next Week

Start Date: First Week in October

Medical Device- NPI Manufacturing Engineer

Location: North San Jose, CA

Duration: Multiyear Contract, Plans to Extend

Vacation Time: 13 days of PTO+ 9 paid holidays

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

W2 Employment Opportunity - Unable to Offer Sponsorhsip

Interviews: Next Week

Start Date: First Week in October

Medical Device- NPI Manufacturing Engineer

Location: North San Jose, CA

Duration: Multiyear Contract, Plans to Extend

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

Vacation Time: 13 days of PTO+ 9 paid holidays

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

Desired Skills and Experience

Targeting:

• -4+ years of experience
• Preference for electromechanical medical device/or capital equipment experience
• DFM/DFA/DFX background

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.