Sr. Manufacturing 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 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:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Manufacturing 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 Sr. Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Senior Manufacturing 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 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 company products, including new products and products already in production. 

• Identify process requirements, advise and support operations management, and implement equipment and fixtures 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 other Quality System requirements. 

• 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 technical development. 

• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new 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 Engineering.

• Minimum five (5) years of experience in a medical device environment or 3 years of experience with a master's degree.

• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)

• Experience implementing Lean and Lean Sigma concepts.

• Experience with Validation of Medical Devices (IQ-OQ-PQ).

• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.

• Ability to use special software such