Staff Manufacturing Mechanical Engineer

Johnson & Johnson Innovative Medicine•San Jose, CA

7d•$118,000 - $179,036•Onsite

About The Position

Johnson & Johnson's MedTech Surgery team at MONARCH is recruiting a Staff Manufacturing Mechanical Engineer for its Robotics & Digital Solutions organization. Based in San Jose, California, this role provides hands-on mechanical engineering support for Monarch capital equipment, including sustaining design, global bill of materials (BOM) management, manufacturing support, design transfer, product quality, obsolescence management, investigations, and continuous improvement. The role is fully onsite and may require up to 10% domestic and/or international travel based on business needs. The engineer supports Monarch systems, assemblies, accessories, and related manufacturing processes throughout their lifecycle. The role works across R&D, Manufacturing, Quality, Service, Supplier Quality, Operations, and external manufacturing partners to maintain product configuration, investigate and resolve quality or production issues, manage engineering changes, transfer designs into production, and improve product and process performance. The position also develops and modifies mechanical designs, drawings, and documentation; supports prototyping, qualification, and manufacturing readiness; and ensures engineering records are accurate, traceable, and audit-ready.

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 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 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.
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 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 that uses 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 releases, software releases without hardware changes, design changes, component replacements, and configuration updates; support BOM merges and preserve configuration integrity.
Lead or support mechanical root-cause investigations related to manufacturing issues, field complaints, service findings, product quality events, and supplier concerns.
Review complaints proactively 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 root-cause assessments, corrective actions, effectiveness checks, and closure documentation.
Support Quality initiatives, including CTQ activities, template updates, documentation improvements, and process standardization.
Lead or support external manufacturing transfers, ensuring mechanical design requirements, drawings, BOMs, tooling, documentation, and production requirements are transferred successfully.
Support Product Quality Planning (PQP), Supplier Change Notifications (SCN), design transfer, and manufacturing-readiness activities.
Partner with cross-functional teams to ensure mechanical design changes are production-ready and manufacturing impacts are understood early.
Lead or support mechanical component and material obsolescence management; 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, tolerance requirements, specifications, assembly documentation, and product configuration information.
Apply DFM/DFA principles and tolerance analysis, including appropriate GD&T, 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, incorporating 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 engineering 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 product reliability, manufacturing efficiency, supply continuity, cost, serviceability, and lifecycle performance.

Benefits

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short- and long-term disability insurance
Business accident insurance
Group legal insurance
Pension plan
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year (56 hours for employees residing in Washington)
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 birth, adoption, or foster-care placement
Condolence leave: 30 days for an immediate family member or 5 days for an extended family member
Caregiver leave: 10 days
Volunteer leave: 4 days
Military spouse time-off: 80 hours