Johnson & Johnson MedTech · 9 hours ago
Sr. MFG Engineer – NPI
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $175K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, and they are seeking a Senior NPI Mechanical Engineer to join their team in Santa Clara, CA. The role focuses on leading new product introduction activities for advanced robotic medical devices, ensuring seamless transitions from design to manufacturing while addressing technical challenges with urgency.
Hospital & Health Care
Responsibilities
Lead mechanical DFM (Design for Manufacturing) activities for complex robotic assemblies and subsystems, identifying and resolving manufacturing constraints with a sense of urgency
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
Monitor, coach, and mentor junior engineers and technicians on manufacturing best practices
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
Collect data and analyze process performance and capabilities for company products, including new products and products already in production
Establish strong working relationships with R&D, Development Engineering, QA, and Production departments to design, develop, test, document, and implement processes, tooling, and fixtures
Support and work with Quality to proactively address and resolve non-conformances before they impact production
Identify process requirements, advise and support operations management, and implement equipment and fixtures needed for process development and manufacturing efforts
Maintain attention to detail while moving at pace, ensuring nothing falls through the cracks
Qualification
Required
Bachelor's degree in mechanical engineering or related field
Minimum 5 years of manufacturing engineering experience with demonstrated progression of responsibility
Strong manufacturing engineering background in BOM structure, process documentation (MPI, DHR, MES), and PFMEA
Experience with robotic systems, precision mechanisms, or electromechanical assemblies strongly preferred
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
Quality Systems: Over 3 years in J&J (or equivalent regulated environment), fully trained and proficient in J&J systems, SOPs, and processes
Documentation: Proven experience developing design control documentation, manufacturing procedures, and quality system records
Preferred
Master's degree in Mechanical Engineering
Experience with surgical robotics platforms or high-precision medical devices
Background in high-mix, low-volume precision manufacturing environments (4-8 units/month scale)
Lean Manufacturing or Six Sigma certification with demonstrated application
Experience with MES systems and PLM tools in regulated industries
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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