Supplier Engineer - Shockwave Medical
About The Position
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 Overview of the position 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.
Requirements
- Bachelor’s degree on Mechanical Engineering or related field.
- Between 0-3 years of experience in a medical device environment.
- 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.
- 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.
Nice To Haves
- Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
- Knowledge with SolidWorks a plus
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
