Supplier Engineer - Shockwave Medical

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 for complex calcified cardiovascular disease. 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. This includes 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 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 conduct make‑vs‑buy assessments used as input to site planning. Perform validation protocols and complete validation reports. Maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions. Support cost‑effective manufacturing processes and improve product flow, product quality, and safety performance for both sustained 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 analysis for cost reduction, 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 to determine root cause, improve product reliability and performance, and implement effective containment and countermeasures. 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) 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. Experience with SolidWorks 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 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 position is eligible for an annual performance bonus in accordance with the Company’s applicable plan. Employees may be eligible to participate in the Company’s sponsored 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)). Time‑off benefits include: vacation – up to 120 hours per calendar year; sick time – up to 40 hours per calendar year (up to 56 hours for Washington state residents); 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 #J-18808-Ljbffr 6947-SHOCKWAVE MEDICAL INC. Legal Entity