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Johnson & Johnson's Shockwave Medical division is seeking a Senior NPI (New Product Introduction) Engineer to join the Santa Clara, CA team. This role is responsible for designing, developing, testing, documenting, and implementing manufacturing processes, tooling, and fixtures throughout the product lifecycle—from design through production and commercialization.
Shockwave Medical specializes in Intravascular Lithotripsy (IVL) technology, a differentiated approach using sonic pressure waves to treat calcified plaque in complex cardiovascular disease. The Senior NPI Engineer will be central to scaling these innovative medical devices for commercial production.
Key responsibilities include:
- Collaborating with R&D, Quality Assurance, Regulatory Affairs, and Production teams to design and implement manufacturing processes and tooling
- Collecting and analyzing process performance data; identifying requirements for new process development
- Developing and maintaining comprehensive documentation aligned with FDA, ISO, MDR, and other quality system requirements
- Prototyping and scaling product designs and test methods for commercialization
- Developing and executing process verification and validation protocols
- Serving as the primary manufacturing point of contact on cross-functional project activities
- Leading continuous improvement initiatives using DMAIC methodology and Lean manufacturing principles
- Performing cost analyses and identifying cost reduction opportunities
- Supporting supplier selection and process development with Procurement and R&D
Required qualifications:
- Bachelor's degree in Mechanical or Biomedical Engineering
- Minimum 5 years of experience in a medical device manufacturing environment
- Strong knowledge of Quality System Regulations (QSRs), FDA, ISO, MDD, MDR compliance
- Understanding of Lean and Six Sigma methodologies
- Experience with medical device validation (IQ-OQ-PQ protocols)
- Proficiency in SolidWorks for drawing creation and maintenance
- Experience with ERP and MES systems (Oracle preferred)
Preferred qualifications include basic statistics knowledge (Cpk, hypothesis testing, DOE, Gage R&R), experience with disposable peripheral and coronary device design, and background in early-stage catheter-based cardiovascular device projects.
