Senior Sustaining Engineer

Senior Sustaining Engineer – Job Summary Johnson & Johnson MedTech is seeking a Senior Sustaining Engineer to support the MONARCH platform in Santa Clara, CA. The role focuses on lifecycle support for commercially released medical instruments and capital equipment, working cross‑functionally to ensure product safety, performance, and regulatory compliance throughout the product lifecycle. Key Responsibilities Provide technical ownership of lifecycle support for MONARCH platform medical devices and related capital equipment. Lead root‑cause investigations and resolution of field issues, complaints, nonconformances, and CAPA. Assess design and process changes for impact on safety, performance, verification/validation, and regulatory submissions. Coordinate with cross‑functional teams (Instruments & Accessories, Vision, Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering) to drive design updates, process improvements, and documentation changes. Create and maintain documentation per Quality System requirements, including test protocols, test reports, engineering studies, drawings, and design history files. Manage system configurations and alignment into country‑specific Bills of Materials (BOMs). Support external manufacturing transfers, including Product/Process Qualification Plans (PQP) and supply chain notifications. Oversee component end‑of‑life (EOL) activities, including impact assessment and mitigation plans. Conduct risk assessments and update risk documentation in coordination with cross‑functional teams. Qualifications Bachelor’s Degree in Engineering or a related field. Minimum 4 years of sustaining engineering or product lifecycle support experience in a regulated industry (medical device, aerospace, automotive, or similar). Strong experience in Design Control and cross‑functional teamwork, bringing products from concept to commercialization in a regulated environment. Demonstrated experience designing and building test equipment and fixtures. Knowledge of component manufacturing processes (cabling, assembly, fabrication, 3D printing). Familiarity with mechanical design, mechatronics, sensors, electronics, and software management. Strong analytical skills, data analysis and statistics. Proficiency in CAD software (e.g., SolidWorks). Excellent communication, organization, and multi‑tasking skills. Ability to work in Santa Clara, CA; remote work not supported. Compensation and Benefits Base pay range: $125,000.00 – $201,250.00 . Eligible for an annual performance bonus and the company’s long‑term incentive program. Benefits include: Medical, dental, vision, life insurance Short‑ and long‑term disability, business accident insurance, group legal insurance Consolidated retirement plan (401(k)) with employer match Paid time off: Vacation (up to 120 hours per calendar year), Sick time (up to 40 hours), Holiday pay (up to 13 days), Work/family leave (up to 40 hours) Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities. We are committed to an inclusive interview process and accommodations are available for applicants with disabilities. #J-18808-Ljbffr