Senior Industrialization/Scale-Up Engineer- Med Dev- San Jose

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

Benefits offered by this job

Health insurance

Dental

Vision

401K enrollment

13 days PTO + 9 holidays

Job summary

Specialist Staffing Group in North San Jose, CA seeks a Medical Device Senior Industrialization/Scale-Up Engineer to lead manufacturing projects from concept through implementation, developing and launching manufacturing processes, equipment, automation, and production lines for high-complexity assemblies.

The role balances hands-on floor work with project leadership, guiding NPI activities, design transfer, root-cause investigations, and continuous improvement.

Qualifications

• Experience leading medical device manufacturing scale-up projects.
• Ability to drive NPI and design transfer across functions.
• Proven problem-solving skills for electromechanical systems.

Responsibilities

• Own manufacturing projects from concept through implementation.
• Develop and launch processes, equipment, automation, and lines.
• Define validation strategies, project plans, and timelines.
• Troubleshoot complex electromechanical systems.
• Lead cross-functional teams through technical challenges.
• Support NPI, scale-up, and design transfer activities.
• Drive root cause investigations and sustainable solutions.

Skills

Manufacturing

Scale-Up

NPI

Lean manufacturing

CAD design

Root cause analysis

Cross-functional leadership

Job description

W2 Employment Opportunity- Unable to Offer Sponsorship

Interviews: This week and early next

Start Date: Mid November

Medical Device- Senior Industrialization/Scale-Up 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

Industrialization/Scale-Up/Factory

• Own manufacturing projects from concept through implementation with minimal direction.
• Develop and launch manufacturing processes, equipment, automation, and production lines.
• Define validation strategies, project plans, and execution timelines.
• Troubleshoot complex mechanical and electromechanical systems.
• Lead cross-functional teams through ambiguous technical challenges.
• Support NPI, manufacturing scale-up, and design transfer activities.
• Drive root cause investigations and implement sustainable solutions.
• Balance hands-on factory-floor execution with project leadership.
• Partner with Engineering, Quality, and Operations to ensure manufacturing readiness.
• Demonstrate a track record of delivering projects from requirements through implementation.

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

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.