Supplier 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 Med Tech, 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

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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 Supplier 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 Supplier Engineer will be responsible for providing technical support to the contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products. Including evaluation and building of prototypes, pilot, and production equipment or tooling as appropriate, troubleshooting and implementing changes to improve manufacturing quality and product performance.

Essential Job Functions

* Work collaboratively with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process.

* Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers.

* Work with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning.

* Perform validation protocols and completion of validation reports.

* Maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.

* Support efforts with cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products.

* Collaborate with cross-functional teams during development phase(s) and provide inputs and recommendations for design for manufacturability (DFM).

* Assist with tests and implements tools, fixtures and equipment required for manufacturing processes.

* Support improvements for mechanical equipment features like 3D Printing, UL Impact testing, and Material selection.

* Perform analysis for cost reduction, and quality and efficiency improvement.

* Support design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.

* Assist suppliers in product failure investigations required to determine root cause, improve product reliability, performance improvement as well as effective containment and counter measures.

* Perform other responsibilities and duties as assigned.

Requirements

* Bachelor's degree on Mechanical Engineering or related field.

* Between 0-3 years of experience in a medical device environment.

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

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

*…