Staff NPI Engineer - MedTech Catheter & Device Dev
Quest Oracle Community
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Benefits offered by this job
Job summary
Johnson & Johnson is seeking a Staff NPI Engineer - Shockwave Medical to join our team in Santa Clara, CA. You will develop and implement manufacturing processes for intravascular lithotripsy devices, guiding products from development into production.
The role emphasizes design for manufacturability, PFMEAs, regulatory readiness, and collaboration with R&D, Operations, and Quality to meet aggressive launch timelines.
Qualifications
- Bachelor's or Master's degree in Mechanical or Biomedical Engineering with related experience.
- Experience in the medical device industry and QSRs/regulatory standards.
- Lean Six Sigma knowledge and statistical analysis skills.
- Strong cross-functional communication and problem-solving abilities.
Responsibilities
- Design, develop, test, document, and implement processes and fixtures for manufacturing.
- Develop and maintain test methods and new catheter manufacturing processes.
- Create and manage technical documentation and design controls.
- Lead PFMEAs, design reviews, and process validation activities.
- Collaborate with R&D, QA, Operations, Regulatory, and Quality teams.
Skills
Education
Tools
Job description
Johnson & Johnson is seeking a Staff NPI Engineer - Shockwave Medical to join our team in Santa Clara, CA. You will develop and implement manufacturing processes for intravascular lithotripsy devices, guiding products from development into production.
The role emphasizes design for manufacturability, PFMEAs, regulatory readiness, and collaboration with R&D, Operations, and Quality to meet aggressive launch timelines.
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