Supplier Engineer - Shockwave Medical

Johnson & Johnson is hiring for a Supplier Engineer – Shockwave Medical to join our team located in Santa Clara, CA . Position Overview The Supplier Engineer will provide technical support to contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products. Responsibilities include evaluating and building prototypes, pilots, and production equipment or tooling, troubleshooting, and implementing changes to improve manufacturing quality and product performance. Essential Job Functions Work collaboratively with contract manufacturers and external partners to transfer and scale Shockwave manufacturing processes. Support development transfer activities from R&D & Operations to contract manufacturers/suppliers. Work with local and international suppliers and manufacturing sites to generate capacity/capability models and perform make‑vs‑buy assessments for site planning. Perform validation protocols and complete validation reports. Maintain process risk documentation (e.g., PFMEA) to identify risks and implement preventive and corrective actions. Support cost‑effective manufacturing processes and improve product flow, quality, and safety performance for both existing and new products. Collaborate with cross‑functional teams during development phases and provide inputs and recommendations for design for manufacturability (DFM). Assist with tests and implement tools, fixtures, and equipment required for manufacturing processes. Support improvements for mechanical equipment features such as 3D printing, UL impact testing, and material selection. Perform cost‑reduction, quality, and efficiency analyses. 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 to determine root causes, improve reliability, performance, and implement effective containment and corrective measures. Perform other responsibilities and duties as assigned. Requirements Bachelor’s degree in Mechanical Engineering or a related field. 0‑3 years of experience in a medical device environment. Proficiency in statistics (Cpk, hypothesis testing, DOE, Gage R&R) is a plus. Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements). Knowledge of lean manufacturing, design for manufacturability, and test implementation. Experience with SolidWorks is a plus. Strong problem‑solving and analytical skills; experience with statistical analysis and design of experiments for product optimization and validation activities. Excellent organizational, verbal, and written communication skills and meticulous attention to detail. Ability 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 25 lbs. Additional Information 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 applicable plan. Employees and/or eligible dependents may be eligible to participate in company‑sponsored employee benefit programs including 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 time‑off benefits: Vacation – up to 120 hours per calendar year Sick time – up to 40 hours per calendar year (up to 56 hours for employees residing in the State of Washington) Holiday pay, including floating holidays – up to 13 days per calendar year Work, personal and family time – up to 40 hours per calendar year Additional information can be found at Salary Range $62,000.00 – $100,050.00 #J-18808-Ljbffr Shockwave Medical