Staff Quality Engineer, Life Cycle Management (LCM)

Company: Disability Solutions
Location: Irvine
Posted on: February 1, 2025

Job Description:

Johnson & Johnson Biosense Inc a member of the Johnson & Johnson Family of Companies is recruiting for a Staff Quality Engineer, Life Cycle Management (LCM). This position will be located in Irvine, CA.A pre-identified candidate for consideration has been identified. However, all applications will be considered.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.Position Summary:Plans, supervises, and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Responsible for identifying systemic product issues from trending data and/or customer feedback, conducting in-depth investigations to determine the root cause of the product issues, and develop solutions to eliminate the product issues. The scope of the work will be primarily electrophysiology catheters, cables, and systems from Biosense Webster Inc. Will be considered a subject matter expert (SME) on Quality LCM matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and be resourceful and creative in developing approaches and solutions to problems. Shares technical expertise with others and develop junior level engineers.Key Responsibilities:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The listed requirements are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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• Identifying systemic product issues from post-market surveillance data and/or customer feedback
• Leading root cause investigations into identified product issue(s)
• Conduct Failure analysis into identified product issue(s)
• Developing models to replicate product issues
• Developing solutions to eliminate product issues
• Developing test methodology to verify proposed solutions eliminate the product issues
• Facilitate cross-functional collaboration with other teams in Biosense Webster Inc. to validate and implement solutions to production lines
• Analyzing post-market surveillance data to confirm efficacy of complaints
• Communicating project progress to management and, where applicable, other functional teams within Biosense Webster Inc.
• Writing engineering reports, protocols, work instructions, and test methods.
• Studying engineering specifications, blueprints, test data, manufacturing data, etc. and carrying the understanding forward to solve systemic product issues.
• Performing tolerance stack-ups when required by the project.
• Developing customer requirements and product specifications with validated test methods
• Interfacing between external vendors and core team
• Traveling to customer sites and manufacturing sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities
• Helping develop system verification and validation plans.
• Providing technical mentoring to less experienced engineers and technicians
• Purchasing or designing equipment for product issue analysis that also meet health, safety and environmental standards set by the company.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Other related duties may be assigned.\r\r

Keywords: Disability Solutions, San Bernardino , Staff Quality Engineer, Life Cycle Management (LCM), Engineering , Irvine, California