NPI Manufacturing Engineer

NPI Manufacturing Engineer at Cygnus Professionals Inc. NPI Manufacturing Engineer at Cygnus Professionals Inc. in Santa Clara, California Posted in 1 day ago.

Type:

full-time

Job Description:

• 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 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
• Monitor, coach, and mentor junior engineers and technicians on manufacturing best practices 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
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production Cross-Functional Collaboration & Technical Leadership
• 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

Qualifications Education:

• Bachelor's degree in mechanical engineering or related field
• Minimum 5 years of manufacturing engineering experience with demonstrated progression of responsibility

Experience and Skills:

Required:

• 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
• Medical device industry experience preferred; proven track record in NPI environments highly valued

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