Senior Mechatronics Engineer

Johnson & Johnson Innovative Medicine•Milpitas, CA

About The Position

The Senior Mechatronics Engineer leads the design, development, integration, verification, and lifecycle support of complex systems and equipment in a regulated MedTech environment. The role combines mechanical, electrical and electronic design, controls, software, sensing, motion, robotics, machine vision, instrumentation, and automation to deliver safe, reliable, maintainable, and scalable equipment solutions. The engineer provides technical ownership from stakeholder needs and system requirements through architecture, detailed design, prototyping, integration, verification, validation, deployment, and change control. The position calls for hands-on engineering capability, sound system-level judgment, and leadership across internal functions and external equipment suppliers. It also includes technical direction, mentoring, and contributions to design standards, reusable architectures, engineering tools, and technology roadmaps. Travel is approximately 10–20%, depending on project needs, and may include supplier, partner, manufacturing, installation, FAT/SAT, or other acceptance visits.

Requirements

Bachelor's degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, Robotics Engineering, Controls Engineering, or a closely related engineering discipline.
At least 5 years of relevant experience developing multidisciplinary systems, automation, robotics, medical-device equipment, or production/test equipment.
Demonstrated experience completing multiple stages of the system or equipment design and development lifecycle.
Demonstrated ability to integrate mechanical, electrical/electronic, sensing, controls, and software elements into functioning equipment.
Hands-on experience with sensors, actuators, motors, motion systems, instrumentation, electrical hardware, and associated controls.
Strong system integration, verification, troubleshooting, and structured root-cause-analysis capability.
Experience developing engineering requirements, specifications, drawings, schematics, interface definitions, test methods, protocols, and technical reports.
Experience applying technical risk management, verification methods, configuration/change control, and disciplined design reviews.
Ability to work effectively across engineering disciplines and provide technical direction to suppliers or integration partners.
Proficiency in SolidWorks for mechanical equipment design, 3D parts and assemblies, engineering drawings, tolerance definition, configuration management, and design for manufacture and assembly.
Working capability with Altium Designer for electrical schematic capture, PCB layout/design review, component libraries, design outputs, and electrical/electromechanical interface development.
Practical use of Python for engineering automation, equipment and instrument integration, test sequencing, data acquisition, data analysis, troubleshooting tools, or verification applications.
Capability in mechatronic system architecture, including requirements allocation, interface management, component selection, trade studies, integration planning, and system-level verification.
Experience integrating electrical and controls systems, including sensors, actuators, motors, servo/stepper motion, safety circuits, industrial I/O, communications, instrumentation, and control-panel interfaces.
Knowledge or experience with PLC-based controls, robotics, machine vision, data acquisition, and automated test or manufacturing equipment.
Knowledge or experience with DFMEA/FMEA, hazard and fault analysis, tolerance analysis, root-cause analysis, verification and validation, reliability, and design reviews.
Strong systems thinking, technical ownership, and accountability.
Analytical, hands-on, structured problem-solving ability.
Clear technical communication and disciplined documentation.
Effective cross-functional collaboration and ability to influence without formal authority.
Sound engineering judgment across performance, safety, quality, compliance, schedule, cost, and lifecycle considerations.

Nice To Haves

Master's degree in Mechatronics, Robotics, Mechanical Engineering, Electrical Engineering, Systems Engineering, Controls Engineering, or a related discipline.
Experience developing systems or equipment in medical devices or another highly regulated industry.
Experience with design controls, requirements traceability, equipment qualification, and risk management in accordance with applicable quality-system practices.
Experience with servo motion, robotics, machine vision, precision mechanisms, industrial controls, data acquisition, instrumentation, and industrial communications.
Experience with Rockwell Automation/Allen-Bradley, Siemens, Beckhoff, National Instruments, Cognex, Keyence, Universal Robots, FANUC, ABB, or comparable platforms.
Working knowledge of FDA quality-system expectations, ISO 13485, ISO 14971, GMP, machine safety, equipment qualification, and engineering change control.
Experience leading equipment suppliers, system integrators, contract manufacturers, or external development partners.
Supplier leadership, technical mentoring, adaptability, and curiosity about emerging technologies.

Responsibilities

Lead end-to-end mechatronic system and equipment development, from requirements and concept selection through architecture, detailed design, integration, verification, validation, release, and lifecycle support.
Translate user and stakeholder needs into clear, testable system, subsystem, interface, and equipment requirements with measurable acceptance criteria and traceability.
Evaluate concepts through feasibility studies, technical trade studies, rapid prototypes, proof-of-concept testing, and risk-based decision making.
Design and integrate mechanical structures and mechanisms, electrical/electronic hardware, sensors, actuators, motors, servo systems, pneumatics, controls, software, robotics, machine vision, instrumentation, and data-acquisition subsystems.
Create and review mechanical models, assemblies, drawings, tolerances, schematics, PCB designs, wiring diagrams, bills of material, interface definitions, and system specifications.
Perform tolerance analysis, component sizing, motion and load analysis, reliability assessment, failure-mode evaluation, and design-for-manufacturability and serviceability reviews.
Plan and execute system integration, design verification, and validation; develop test methods, protocols, fixtures, automated tests, data analysis, and objective acceptance criteria.
Lead multidisciplinary troubleshooting and root-cause analysis across mechanical, electrical, controls, software, sensing, communications, and product/equipment interfaces.
Apply design controls, DFMEA/FMEA, hazard analysis, machine-safety principles, fault analysis, risk controls, and documented design reviews throughout development.
Develop equipment architectures with interlocks, diagnostics, error handling, fault recovery, calibration, maintainability, and serviceability.
Provide technical direction to system integrators, equipment suppliers, and technology partners through specifications, design reviews, supplier risk management, FAT/SAT, qualification, and acceptance.
Support equipment qualification, applicable process validation, technology transfer, manufacturing readiness, production ramp, engineering change control, obsolescence management, and lifecycle improvements.
Mentor engineers and technicians and contribute to common design standards, reusable architectures, engineering tools, technology roadmaps, and lessons learned.
Independently own technically complex equipment or major system/subsystem development workstreams.
Lead architecture, design, integration, verification, and technical risk reviews using requirements, data, and engineering fundamentals.
Identify technical and interface risks early, establish mitigation plans, and drive issues to documented closure.
Influence R&D, Systems Engineering, Quality, Manufacturing, Operations, Regulatory, Supply Chain, Service, and external suppliers without relying on formal authority.
Communicate designs, trade-offs, risks, test results, and recommendations clearly to technical and non-technical stakeholders.
Promote engineering rigor, modularity, standardization, and design reuse while mentoring less-experienced engineers and technicians.