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Johnson & Johnson is hiring for aSr. Supplier Engineer - Shockwave Medicalto join our team located inSanta Clara CA.

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. .

Essential Job Functions

• 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.

Requirements

• Bachelors 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.

• Experience with software upgrades or validation is a plus. 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.

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 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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

• Additional information can be found through the link below.

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The anticipated base pay range for this position is :

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