Sr. Supplier Engineer - Shockwave

Johnson & Johnson • Santa Clara, CA

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About The Position

Johnson & Johnson is hiring for a Sr. 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 Sr. Supplier Engineer is responsible for providing engineering support to Production team and external contract manufacturers.. This position leads the development, validation, and implementation of test equipment and fixtures for both development & commercial products. This role will troubleshoot complex and contributes to the resolution of technical challenges across Electrical and mechanical systems, support product transfers, and collaborate cross-functionally to ensure scalable, reliable and efficient manufacturing processes.

Requirements

• Bachelor’s degree in Electrical Engineering or related discipline.
• Minimum of 5 years of relevant experience, preferably in the medical device industry.
• Knowledge of Quality System requirements such as ISO and other applicable regulatory standards.
• Proven experience with test equipment design, validation protocols, and root cause analysis.
• Strong understanding of electrical schematics and mechanical drawings.
• Strong understanding of electrical schematics and mechanical drawings.
• Ability manage multiple priorities in a fast-paced environment.
• Strong problem-solving skills with the ability to work independently or as part of a team.
• Willingness to travel to supplier sites as needed (including occasional overnight travel).
• Must be able to lift up to 25 lbs or more and work in both air-conditioned office space and non-temperature controlled warehouse space.

Nice To Haves

• Experience with software upgrades or validation is a plus.

Responsibilities

• Serve as the primary technical point of contact for contract manufacturer and external partners, supporting the transfer and scale up of manufacturing processes.
• Supports development transfer activities between NPD, and operations to contract manufacturer/external partner.
• Design, develop, and maintain process risk documentation (e.g., PFMEA) to proactively identify and mitigate potential manufacturing issues.
• Prepare and execute engineering change orders and coordinate implementation activities, including training for production staff.
• Provides expertise in project planning and timeline development & management and maintain project schedules and timelines.
• Design, develop, and maintain testing fixtures, equipment, and manufacturing tools to support production and product validation.
• Collaborates with cross-functional teams to provide design for manufacturability (DFM) feedback during development phases.
• Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes.
• Develop manufacturing process documentation, including work instructions, inspection plans and lot history travelers.
• Perform cost-reduction analysis and lead initiatives to improve product quality, and process efficiency.
• Lead the design transfer of new products to production, including establishing assembly time and yield targets, training, and quality control.
• Investigate product failures in collaboration with contract manufacturers to determine root cause and implement corrective actions to improve product reliability and performance.
• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, ISO standards, and internal quality systems.
• Ability to understand schematics and PCBA layout.
• Execute and document test protocols and reports for validating test equipment and medical devices.
• Troubleshoot and repair complex systems to the component level using schematics, layouts, and diagnostic tools.
• Provide hands-on support using standard laboratory equipment (Ex. Scope, multimeter, etc.)
• Support software upgrades and work with programming tools.
• Perform additional tasks and duties as assigned.

Benefits

• This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level