Supplier Engineer - Shockwave Medical

Johnson & Johnson is hiring a Supplier Engineer – Shockwave Medical in Santa Clara, CA.

Supply Chain Engineering

Manufacturing Engineering

Scientific/Technology

Santa Clara, California, United States of America

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.

• 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.

• Bachelor’s degree in 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.
• Knowledge of lean manufacturing, design for manufacturability and test implementation.
• Knowledge with Solid Works a plus.
• Strong problem‑solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities.
• Excellent organizational, verbal, and written communication skills as well as attention to detail.
• Able to interface with all levels and functions of the organization; requires a cooperative team‑balanced perspective for appropriate output and task outcome.
• Employee may be required to occasionally lift objects up to 25lbs.

The Company maintains highly competitive, performance‑based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company-sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including floating holidays – up to 13 days per calendar year
  • Work, personal and family time – up to 40 hours per calendar year

$62,000.00 - $