Senior Industrialization​/Scale-Up Engineer- Med Dev

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

• 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.

• 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

• 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

• 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.