Job Function: R&D Product Development
Job Sub Function: R&D Mechanical Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Santa Clara, California, United States of America
Job Description:Johnson & Johnson MedTech is recruiting for a
Senior Sustaining Engineer within our MedTech 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. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.
Johnson & Johnson MedTech 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 MONARCH Platform. The Senior Sustaining Engineer will be part of cross-functional teams (including 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.
Key Responsibilities:- 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.
- 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.
QualificationsRequired Knowledge/Skills, Education, And Experience:- 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 industry (medical device, aerospace, automotive, or similar).
- Conduct risk assessments and coordinate with cross-functional teams to update risk documentation.
- Strong experience in Design Control and working in a cross-functional team setting bringing products from concept to commercialization in regulated industry (including medical device, automotive, aerospace).
- Demonstrated experience in designing and building test equipment and fixtures.
- Working knowledge of component manufacturing processes (cabling, assembly, fabrication, 3D printing).
- Knowledge of mechanical design, mechatronics, sensors, electronics and software management.
- Strong understanding of data analysis and statistics.
- Proficiency in CAD software (e.g., SolidWorks).
- Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Must be highly organized with the ability to work on multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
- Ability to work at Santa Clara, CA site.
The anticipated base pay range for this position is $125,000.00 to $201,250.00
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be 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.
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Required Skills:Design Control Process, Fixtures Design, Manufacturing Processes, Risk Assessments, Test Equipment Design
Preferred Skills:Business Case Modeling, Coaching, Critical Thinking, Design Thinking, Feasibility Studies, Mechanical Engineering, Problem Solving, Process Oriented, Product Design, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Technologically Savvy
The anticipated base pay range for this position is :$125,000.00 - $201,250.00
Additional Description for Pay Transparency:
