Staff Manufacturing Mechanical Engineer

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Mechanical Engineering Job Category: Scientific/Technology All Job Posting Locations: San Jose, California, United States of America Job Description: Johnson & Johnson's MedTech Surgery team at MONARCH is recruiting for a Staff Manufacturing Mechanical Engineer within our Robotics & Digital Solutions (RAD) organization. This role will provide hands-on mechanical engineering support for Monarch capital equipment, with responsibilities spanning sustaining design, global BOM management, manufacturing support, design transfer, product quality, obsolescence management, investigations, and continuous improvement. This role is based in San Jose, California. Our MedTech team is working to solve 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 combines our surgical portfolio with Robotics & Digital technologies to advance the future of surgery. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that is reimagining how we heal? Our Surgery team will give you the opportunity to deliver technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help support the treatment of prevalent conditions such as lung cancer and kidney stones. Patients are waiting. Key Role Responsibilities Provide hands-on development and sustaining mechanical engineering support for Monarch capital systems, assemblies, accessories, and related manufacturing processes. Own and maintain global BOM structures to ensure accurate product configuration across R&D, Manufacturing, Service, Operations, and external manufacturing partners. Manage and support BOM changes associated with sustaining releases, incremental software releases with no hardware changes, design changes, component replacements, and configuration updates. Support BOM merge activities and ensure product configuration integrity through design and manufacturing changes. Lead or support mechanical root-cause investigations associated with manufacturing issues, field complaints, service findings, product quality events, and supplier-related concerns. Perform proactive and preemptive complaint reviews to identify recurring mechanical issues, emerging trends, and opportunities for design or manufacturing improvement. Lead or support CAPA and nonconformance investigations involving mechanical components, assemblies, systems, and manufacturing processes. Develop technically sound root-cause assessments, corrective actions, effectiveness checks, and documentation required to achieve timely closure. Support Quality initiatives including Critical-to-Quality (CTQ) activities, template updates, documentation improvements, and process standardization. Lead or support external manufacturing transfers and ensure mechanical design requirements, drawings, BOMs, tooling, documentation, and production requirements are successfully transferred. Support Product Quality Planning (PQP), Supplier Change Notifications (SCN), design transfer, and manufacturing-readiness activities. Partner with R&D, Manufacturing, Quality, Service, Supplier Quality, and Operations to ensure mechanical design changes are production-ready and manufacturing impacts are understood early. Lead or support mechanical component and material obsolescence management. Identify replacement components, materials, or suppliers while maintaining product form, fit, function, reliability, performance, and regulatory compliance. Develop and modify mechanical parts and assemblies using SolidWorks or equivalent CAD tools. Generate and review engineering drawings, tolerance requirements, specifications, assembly documentation, and product configuration information. Apply DFM/DFA principles to improve manufacturability, assembly efficiency, product reliability, serviceability, and cost. Perform tolerance analysis and apply appropriate GD&T principles when evaluating or implementing mechanical changes. Support prototype fabrication, rapid prototyping, engineering builds, verification, and hands-on evaluation prior to final design release when appropriate. Evaluate proposed design changes for form, fit, function, usability, repairability, durability, manufacturability, and long-term production support. Incorporate feedback from manufacturing operators, technicians, Service, Quality, R&D, and other stakeholders into mechanical design decisions. Lead or support qualification activities (IQ/OQ/PQ) for equipment being introduced to production. Support production line issues, rework activities, tooling and fixture needs, supplier changes, and manufacturing process improvements. Drive engineering changes through Agile-EC or applicable engineering change-control processes. Clearly communicate technical risks, recommendations, timelines, blockers, and required actions to stakeholders. Ensure engineering documentation, investigations, BOM changes, drawings, specifications, and technical justifications are complete, accurate, traceable, and audit-ready. Support continuous improvement initiatives that improve product reliability, manufacturing efficiency, supply continuity, cost, serviceability, and lifecycle performance. Required Qualifications Minimum a bachelor’s degree or equivalent experience in Mechanical Engineering, Mechatronics, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline; advanced degree in a relevant engineering field is preferred. Relevant professional experience in mechanical design, sustaining engineering, manufacturing engineering, product development, or related engineering functions. Strong hands-on mechanical design and problem-solving experience. Proficiency with 3D CAD software and engineering drawings. Strong understanding of mechanical design principles, materials, manufacturing processes, assembly methods, tolerance analysis, and product configuration. Demonstrated ability to conduct structured root-cause investigations and translate findings into practical engineering solutions. Experience with engineering change control, BOM management, design documentation, and product lifecycle activities. Experience working cross-functionally with R&D, Manufacturing, Quality, Service, Supplier Quality, Operations, and external manufacturing partners. Knowledge of good manufacturing practices and documentation requirements for production processes. Strong understanding of validation, documentation control, Quality Systems, and regulated product environments. Strong written and verbal communication skills. Ability to independently manage multiple activities and drive deliverables through closure. Demonstrate Credo-based leadership and collaboration. Preferred Qualifications Master’s degree, PhD, or equivalent experience in Mechanical Engineering, Mechatronics, Biomedical Engineering, Manufacturing Engineering, or a