Sr. NPI Engineer - Shockwave Medical

Senior NPI Engineer – Shockwave Medical

Johnson & Johnson is hiring for a Senior NPI Engineer – Shockwave Medical to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The NPI Senior Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. The NPI Senior Engineer will work closely with production, quality, and R&D teams to support the company's manufacturing operations and product launch timelines.

Essential Job Functions

• Work collaboratively with R&D, QA, RA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Support and work with Quality to address and resolve non-conformances.
• Collect data and analyze process performance and capabilities for new processes development company products, including new products and products already in production.
• Identify process requirements, advise and support operations management, design and development implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI's, LHR's), and company's Design Control requirements and consistent with FDA, ISO, MDR and other Quality System requirements.

• Prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization
• Develop protocols/reports and perform process verification and validation testing
• Represents Operations as a primary point of contact on manufacturing-related project activities, including internal and external requests and perform process-related tasks to support pilot manufacturing
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's product.

• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).
• Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
• Assist Procurement and R&D departments with supplier selection and process development.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new and existing products, identify and implement cost reduction plans for existing products).

• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

• Bachelor's degree in Mechanical or Biomedical Engineering
• Min 5 years of experience in a medical device environment.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus.
• Able to create and maintain Drawings in Solid Works.
• Experience with ERP and MES (Oracle preferred)
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
• Experience in early-stage catheter based cardiovascular devices project is a strong plus
• Effective communication skills with all levels of management and organizations
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25lbs or more.
• Employee will be required to work in an air-conditioned Class 8 Cleanroom.

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 as defined under VEVRAA and Section 503 of the Rehabilitation Act.

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