NPI Manufacturing Engineer

• 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 strategiesManufacturing 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 practicesElectromechanical 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 productionCross-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 cracksQualificationsEducation:• Bachelor's degree in mechanical engineering or related field• Minimum 5 years of manufacturing engineering experience with demonstrated progression of responsibilityExperience 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 recordsPreferred:• 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

Created: 2026-05-13