NPI Engineer II - Shockwave Medical

Johnson & Johnson • Santa Clara, CA

2d • Onsite

About The Position

Johnson & Johnson is hiring for a NPI Engineer II – 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. 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 3 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)
• 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.

Nice To Haves

• 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

Responsibilities

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
• Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
• Coordinate and/or perform functional and destructive testing to support Engineering Reports.
• Document the results and provide a statistical analysis using Minitab or excel.
• Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
• Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
• Create, maintain and transfer paper Bill of Materials (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s.
• Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
• Create and release label files used for printing product labels.
• Create and execute process validation protocols and reports.
• 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
• 10 days 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: Mid Level