Staff Microbiology Specialist

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Microbiology Specialist – 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 Microbiology Specialist 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. Staff Microbiology Specialist provides Quality Assurance support to functions with a focus on Microbiology aspects, as part of sustaining and design control activities in accordance with ISO 13485, ISO 14971, ISO 11137, ISO 11737, ISO 11135, ISO 14644, ISO 8573, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other relevant standards/regulations. This includes supporting project teams across multiple SWMI sites/business units to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines.

Essential Job Functions

• Ensures Actively participate in Design Control activities such as:

• Lead Microbiology and Sterilization related activities:

• Establish validated sterilization cycle and ongoing process controls.

• Assess sterilization cycle for adoption to other product families.

• Perform assessment of sterile barrier and packaging controls to ensure integrity of validated sterilization cycle.

• Identify appropriate microbiology test criteria for in process and final product testing (e.g. pyrogen, bacteriostasis/fungi stasis and bioburden) and establish ongoing process controls as part of Design Transfer.

• Identify and qualify suppliers and complete testing per approved protocols.

• Based on assessment or test results, establish relevant limits to ensure microbiology parameters are tracked and trended

• Ensure test methods used as part of Design Controls are validated.

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

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