Senior Sustaining Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

Senior Sustaining Engineer responsible for lifecycle support of commercially released medical instruments and capital equipment for the MONARCH Platform. This role involves leading failure investigations, driving design and process improvements, managing component obsolescence, and ensuring product safety, performance, and regulatory compliance within a regulated medical device environment.

What you'd actually do

  1. Technical ownership for lifecycle support of commercially released medical device instruments and capital equipment to ensure continued safety, performance, quality, and regulatory compliance.
  2. Lead root cause investigations and resolution efforts for field issues, complaints, nonconformances, and CAPA.
  3. Assess design and process changes for impact to safety, performance, verification/validation, and regulatory submissions.
  4. Coordinate with cross functional teams to drive design updates, process improvements and documentation changes.
  5. Create documentation including test protocols, test reports, engineering studies, drawings, and other technical documents in accordance with Quality System requirements.

Skills

Required

  • 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.

What the JD emphasized

  • regulated industry
  • Design Control