Experienced NPI Manufacturing Engineer

Johnson & Johnson Innovative Medicine • San Jose, CA

2d • $91,000 - $147,200 • Onsite

About The Position

Johnson & Johnson RAD (Robotics and Digital) is seeking an NPI Manufacturing Engineer – MONARCH, for our San Jose, CA Location. 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. We harness our deep expertise in surgery, orthopedics, vision and interventional solutions to design healthcare solutions that are smarter, less invasive and more personalized. The MedTech Surgery organization was recently established to combine our market-leading surgical portfolio with the Robotics & Digital portfolio. This role will be instrumental in bringing next-generation Instruments and Accessories (I&A) from concept to reality, working on mechanisms that require high level of precision and reliability. This role offers the opportunity to shape manufacturing strategy early in the product lifecycle, preventing costly delays and ensuring our products can scale while meeting the highest quality standards.

Requirements

• A Bachelor’s degree in Engineering is required: Mechanical Engineering, Mechatronics or related field preferred.
• Minimum 4+ years of relevant professional work experience
• Manufacturing engineering experience with demonstrated progression of responsibility
• Experience with fixture design, laser welding, crimping or catheter manufacturing strongly preferred
• Medical device industry experience; proven track record in NPI environments
• CAD design (SolidWorks preferred), rapid prototyping, and fixture design
• Documentation: Experience developing design control documentation, manufacturing procedures, and quality system records
• Lean Manufacturing or Six Sigma certification with demonstrated application
• Proactive Ownership: Takes full accountability for outcomes; identifies and solves problems
• Attention to Detail: Details are right the first time while maintaining momentum on larger objectives
• High Drive: Self-motivated with relentless pursuit of excellence; thrives under pressure and tight timelines
• Proven ability to work collaboratively in cross-functional teams while maintaining individual accountability
• Strong project management skills with ability to juggle multiple parallel NPI programs
• Excellent troubleshooting skills- doesn’t give up until root cause is identified and resolved
• Comfortable challenging technical decisions when manufacturing concerns arise
• Thrives in ambiguity and rapidly changing priorities

Nice To Haves

• Experience with J&J (or equivalent regulated environment), fully trained and proficient in J&J systems, SOPs, and processes
• Experience with surgical robotics platforms or high-precision medical devices

Responsibilities

• Participate in DFM (Design for Manufacturing) & DFA (Design for Assembly) activities for Instruments & Accessories (I&A), identifying and resolving manufacturing constraints
• Develop and maintain comprehensive manufacturing readiness frameworks for I&A product releases.
• Drive cross-functional NPI reviews with R&D, Quality, Supplier Engineering and Production teams to ensure seamless and timely product transitions
• Create NPI project timelines, proactively identifying risks and implementing mitigation strategies
• Design, validate, and document assembly processes, tooling, gauges, and fixtures
• Author and implement manufacturing documentation (MPI, Travelers, PFMEA, Process Maps), including process validation protocols, reports, standard operating procedures, and equipment/fixture specifications.
• Apply lean manufacturing principles in production processes to reduce/eliminate waste and balance lines
• Lead and actively participate in process/product continuous improvement projects with measurable outcomes
• Experienced with Manufacturing troubleshooting capabilities to rapidly resolve build issues
• Lead root cause analysis, diving deep into technical details until problems are fully understood
• 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, QA, Supplier Engineering 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

Benefits

• 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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level