About the Role
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.
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 related technical field.
•Experience in medical device manufacturing or another highly regulated industry.
•12+ years of experience working in the medical device, healthcare, or life sciences industry.
•Strong proficiency with SolidWorks.
•Experience with Agile-EC, Agile PLM, or comparable engineering configuration and lifecycle-management systems.
•Experience managing complex global product BOMs and engineering change processes.
•Experience with robotic systems, capital equipment, complex electromechanical products, or system-level sustaining engineering.
•Experience supporting external manufacturing transfers and supplier transitions.
•Experience with Product Quality Planning (PQP), Supplier Change Notifications (SCN), Critical-to-Quality (CTQ) activities, CAPA, nonconformance investigations, and complaint investigations.
•Experience with component and material obsolescence management.
•Experience with DFM/DFA, tolerance analysis, GD&T, rapid prototyping, machining, sheet metal, molded components, and complex assemblies.
•Knowledge of Quality System, QSIT and FDA guidelines, 21 CFR 820, ISO 13485, ISO 14971, and applicable guidance.
•Familiarity with ETQ, SAP, Agile, Box, Jira, Maximo, Minitab, or similar engineering and quality-system tools.
•Experience supporting NPI, design transfer, sustaining engineering, product lifecycle management, reliability, and manufacturing operations.
•Understanding of standard costs, work standards, and manufacturing data management within SAP or comparable ERP systems.
•Experience with complex equipment that utilizes PLC's, actuators, safety relays and other electromechanical components.
•Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification is preferred.
Other
•This role may require up to 10% domestic and/or international travel based on business needs.
•The attendance policy for this role is fully onsite.
Compensation & Benefits
The anticipated base pay range for this position is $118,000.00 to $179,035.50.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Time off benefits include: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (56 hours for employees residing in Washington State); 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 birth/adoption/foster care of a child; Condolence Leave – 30 days for an immediate family member, 5 days for an extended family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time-Off – 80 hours.
