Staff Supplier Engineer

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:

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 Staff 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 Staff Engineer will be responsible for 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. The Staff Manufacturing Engineer will assist in the identification and pursuit of value improvement and cost improvement projects to support operations in line with business goals and objectives.

Essential Job Functions

• Acts as the primary technical point of contact; works with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process.

• Support supplier selection and qualification to support Global business continuity initiatives.

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

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

• Manage preparation and execution of validation protocols and completion of validation reports.

• Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.

• Provides expertise in project planning and timeline development & management and maintain project schedules and timelines.

• Lead & Implements process improvement and cost reduction projects.

• Effectively utilizes lean manufacturing tools for continuously improving the flow of material and information in the factory including factory layouts, visual management, 6S, JIT, Kanban.

• Implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products.

• Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).

• Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes.

• Develops manufacturing process instructions, inspection plans and lot history travelers

• Performs analysis for cost reduction, and quality and efficiency improvement.

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

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

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

• Performs other responsibilities and dutie