Senior NPI Manufacturing Engineer- Med Dev

W2 Employment Opportunity - Unable to Offer Sponsorship

Interviews: This Week and Beginning of Next

Start Date: First Week in November

Medical Device
- Senior 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

We are seeking a highly capable, hands-on Senior Manufacturing Engineer to lead complex manufacturing projects from concept through implementation. This role requires someone who thrives in ambiguous environments, can independently define project scope and validation strategies, and takes full ownership of execution. The ideal candidate possesses strong mechanical and electromechanical aptitude, excels at troubleshooting sophisticated systems, and has a proven track record of developing, implementing, and optimizing manufacturing processes, equipment, automation systems, and production lines.

• Lead manufacturing projects end-to-end, from requirements definition and planning through validation, implementation, and production launch.
• Develop and execute project plans, validation strategies, risk assessments, and performance metrics for new manufacturing initiatives.
• Design, specify, implement, and optimize manufacturing equipment, automation solutions, and production processes.
• Drive New Product Introduction (NPI), manufacturing scale-up activities, and design transfer into production environments.
• Troubleshoot and resolve complex mechanical, electrical, and electromechanical manufacturing challenges.
• Collaborate cross-functionally with engineering, operations, quality, and suppliers to ensure successful project execution.
• Identify opportunities to improve throughput, quality, reliability, safety, and overall manufacturing performance.
• Provide technical leadership in situations where requirements or direction are not clearly defined, creating the path forward and aligning stakeholders.

• 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.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.