Senior Sustaining Engineer

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, less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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.

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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.

R&D Product Development

R&D Mechanical Engineering

Scientific/Technology

Santa Clara, California, United States of America

Johnson & Johnson Med Tech is recruiting for a Senior Sustaining Engineer within our Med Tech Surgery organization. The location for this position is Santa Clara, CA
. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med‑tech platforms:
Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions.

Johnson & Johnson Med Tech is developing a robotic surgical platform that will set a new standard for the modern OR and transform the surgical experience. OTTAVA is designed as a multi‑specialty soft‑tissue surgery robot, activating the benefits of AI/ML, connecting health data inside the operating room and out.

The Senior Sustaining Engineer will be responsible for lifecycle support of commercially released medical instruments and capital equipment for the MONARCH Platform. The Senior Sustaining Engineer will work as part of cross‑functional teams (Instruments & Accessories, Vision, Mechanical Engineering, Electrical Engineering, Software Engineering and Systems Engineering) that are responsible for failure investigation, design and process improvements, component obsolescence, risk management, manufacturing and field issue resolution.

The position works cross‑functionally with R&D, Quality, Manufacturing, Service, and Regulatory Affairs to ensure continued product safety, performance, and reliability throughout the product lifecycle.

• Technical ownership for lifecycle support of commercially released medical device instruments and capital equipment to ensure continued safety, performance, quality, and regulatory compliance.
• Lead root cause investigations and resolution efforts for field issues, complaints, nonconformances, and CAPA.
• Assess design and process changes for impact to safety, performance, verification/validation, and regulatory submissions.
• Coordinate with cross functional teams to drive design updates, process improvements and documentation changes.
• Create documentation including test protocols, test reports, engineering studies, drawings, and other technical documents in accordance with Quality System requirements.
• Support design documentation updates, including drawings, specifications, and design history files.
• Manage system configurations, including integration and alignment into country‑specific Bills of Materials (BOMs).
• Support external manufacturing transfers, including Product/Process Qualification Plans (PQP) and supply chain notifications.
• Manage component end‑of‑life (EOL) activities, including impact assessment and mitigation plans.
• Conduct risk assessments and coordinate with cross‑functional teams to update risk documentation.

• Bachelor’s Degree in Engineering or related field.
• Minimum of 4+ years of experience in sustaining engineering, product lifecycle support, or related engineering roles within a regulated…