Senior Sustaining Engineer

About the role

Johnson & Johnson MedTech is recruiting for a Senior Sustaining Engineer within our MedTech Surgery organization. The location for this position is Santa Clara, CA.

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.
• Cook 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.

Qualifications

• 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).
• 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.
• Ability to work at Santa Clara, CA site.

Pay

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.

Schedule

The anticipated base pay range for this position is : $125,000.00 - $201,250.00.