Staff Manufacturing Mechanical Engineer

Johnson & Johnson • San Jose, CA

6d • Onsite

About The Position

Johnson & Johnson’s MedTech Surgery team at MONARCH is recruiting a Staff Manufacturing Mechanical Engineer within its Robotics & Digital Solutions organization. Based fully onsite in San Jose, California, this role provides hands-on mechanical engineering support for Monarch capital equipment across sustaining design, global bill-of-materials (BOM) management, manufacturing support, design transfer, product quality, obsolescence management, investigations, and continuous improvement. The role may require up to 10% domestic and/or international travel based on business needs.

The engineer develops and sustains mechanical systems, assemblies, and accessories; manages product configurations and engineering changes; and investigates manufacturing, field, service, supplier, and quality issues. The position partners with R&D, Manufacturing, Quality, Service, Supplier Quality, Operations, and external manufacturing partners to ensure mechanical changes and transfers are production-ready and documented. It also supports manufacturing readiness, equipment qualification, production-line improvements, and product lifecycle performance in a regulated product environment.

Johnson & Johnson’s MedTech organization develops solutions across surgery, orthopedics, vision, and interventional care. The Surgery organization combines its surgical portfolio with Robotics & Digital technologies to advance surgical care, including technologies supporting treatment of conditions such as lung cancer and kidney stones.

Requirements

• Bachelor’s degree or equivalent experience in Mechanical Engineering, Mechatronics, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• Relevant professional experience in mechanical design, sustaining engineering, manufacturing engineering, product development, or a related engineering function.
• 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 production-process documentation requirements.
• 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.

Nice To Haves

• Advanced degree in a relevant engineering field; preferred qualifications include a master’s degree, PhD, or equivalent experience in a related technical field.
• Experience in medical device manufacturing or another highly regulated industry.
• 12 or more years of experience 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 PQP, SCN, 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 using PLCs, actuators, safety relays, and other electromechanical components.
• Lean Six Sigma Green Belt, Black Belt, or equivalent continuous-improvement certification.

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 and product configuration across R&D, Manufacturing, Service, Operations, and external manufacturing partners.
• Manage BOM changes for sustaining and design releases, component replacements, configuration updates, and incremental software releases that do not change hardware; support BOM merges and configuration integrity.
• Lead or support mechanical root-cause investigations involving manufacturing issues, field complaints, service findings, product quality events, and supplier concerns.
• Review complaints proactively to identify recurring mechanical issues, trends, and opportunities for design or manufacturing improvement.
• Lead or support CAPA and nonconformance investigations, including root-cause assessments, corrective actions, effectiveness checks, and documentation.
• Support Quality initiatives, including CTQ activities, template updates, documentation improvements, and process standardization.
• Lead or support external manufacturing transfers, ensuring that mechanical requirements, drawings, BOMs, tooling, documentation, and production requirements are transferred successfully.
• Support Product Quality Planning, Supplier Change Notifications, design transfer, and manufacturing-readiness activities.
• Partner with R&D, Manufacturing, Quality, Service, Supplier Quality, and Operations to ensure mechanical changes are production-ready and manufacturing impacts are understood.
• Manage component and material obsolescence; identify replacements while maintaining form, fit, function, reliability, performance, and regulatory compliance.
• Develop and modify mechanical parts and assemblies using SolidWorks or equivalent CAD tools; generate and review drawings, tolerances, specifications, assembly documentation, and configuration information.
• Apply DFM/DFA, tolerance analysis, and GD&T principles to improve manufacturability, assembly efficiency, reliability, serviceability, and cost.
• Support prototype fabrication, rapid prototyping, engineering builds, verification, and hands-on evaluation before design release when appropriate.
• Evaluate design changes for form, fit, function, usability, repairability, durability, manufacturability, and long-term production support; incorporate stakeholder feedback into design decisions.
• Lead or support IQ/OQ/PQ qualification activities for equipment introduced to production.
• Support production-line issues, rework, tooling and fixture needs, supplier changes, and manufacturing-process improvements.
• Drive engineering changes through Agile-EC or applicable change-control processes.
• 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 reliability, manufacturing efficiency, supply continuity, cost, serviceability, and lifecycle performance.

Benefits

• Medical, dental, and vision insurance.
• Life insurance and short- and long-term disability coverage.
• Business accident insurance and group legal insurance.
• Company consolidated retirement plan (pension) and 401(k) savings plan.
• Eligibility to participate in the long-term incentive program.
• 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 a child’s birth, adoption, or foster-care placement.
• Condolence leave: 30 days for an immediate family member and 5 days for an extended family member.
• Caregiver leave: 10 days.
• Volunteer leave: 4 days.
• Military spouse time off: 80 hours.

What This Job Offers

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