Staff Quality Engineer - Shockwave Medical

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Staff Quality 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.

Position Overview

The Staff Quality Engineer (Design Assurance) works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible.

Essential Job Functions

• Actively participate in Design Control activities such as:

• Ensure new Design projects and Design Change activities are performed in compliance to Design Control procedure.

• Design reviews to document and ensure that the design meets the intended customer requirements.

• Draft Design Verification and Validation Test Protocols, Methods and Reports.

• Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.

• Responsible for ongoing management of Risk Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA.), Risk Management Plans and Reports.

• Perform Design Verification and Validation Testing.

• Lead/Coordinate/perform verification/ validation activities for:

  • Biocompatibility Testing

  • Packaging Validation

  • Accelerated and Real Time Shelf-Life/Aging Studies

  • Sterilization Validation

  • Test Method Validation

  • Human Factors Formative and Summative evaluation

  • Restricted Substance Control and Approved Supplier List

• Identify testing and analysis required for the finished device to ensure conformance to product specifications.

• Develop device Quality Plans t