Sr. NPI Engineer - Shockwave Medical

Johnson & Johnson • Santa Clara, CA

2d • Onsite

About The Position

Johnson & Johnson is hiring for a Senior NPI Engineer – Shockwave Medical to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 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.

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 SolidWorks.
• 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.

Nice To Haves

• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R&R)
• Knowledge of disposable peripheral and coronary device design, material selection, and testing
• Experience in early-stage catheter based cardiovascular devices project

Responsibilities

• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior