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Principal Quality Engineer, New Product Development

Company: Johnson & Johnson
Location: Irvine
Posted on: June 9, 2021

Job Description:

Biosense Webster, Inc. part of the Johnson & Johnson Family of Companies, is recruiting for a Principal Quality Engineer, New Product Development, located in Irvine, CA. Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. (BWI) is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company's CARTO 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure. Biosense Webster is part of the Cardiovascular and Specialty Solutions Group of Medical Device sector of Johnson and Johnson. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit www.biosensewebster.com As a member of our Design Core Team and as a representative of the Quality Engineering department, you will be involved in the development of new technologies for the treatment of various cardiac arrythmia's including atrial fibrillation and ventricular tachycardia, ensuring the safe and effective design of the catheter or system's involved in the treatment. A few of the responsibilities of the Principal Quality Engineer will involve managing a team of Quality Engineers and collaborating with other members of the Design Core Team. Additionally, you will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle. If you are and individual who enjoys working with the other Core Team members and changing the lives of our patients around the world come join our team at Biosense Webster! Key Responsibilities: Representative and/or Lead for the Quality Engineering Department in the New Product Development Core team. Responsible for the Design Verification/Validation activities for the device in development. Compliance oversight over the development activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the New Product Development process. Mechanical drawing review and approval in accordance with ASTM-14.5Y Performs complex tests and analyses to assure that products are aligned with established specifications. Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria. Compiles data and prepares reports on findings, to identify trends, proposes corrective action when necessary. Recommends and implements revisions, corrections and changes to test equipment, procedures, and methods. Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems. Troubleshoots defective products during development/testing phases as well as product which has been returned by customers to resolve root causes of failure. Qualifications Education: A minimum of a Bachelor's Degree in an Engineering discipline. Experience and Skills: Required: A minimum of 10 years working as a Quality Engineer within a regulated industry, preferably Medical Device. Ability to work with MS Excel, Word, SolidWorks and MiniTab. Strong technical writing, problem-solving skills (DMAIC or 6S methodologies). Experience in Risk Management activities in accordance with ISO14971 and applied statistical analysis for the determination of testing acceptance criteria. Geometrical Dimensioning and Tolerancing (GD&T) experience and the ability to identify undefined features. Management skills for a team of up to 5 engineers or contractors. Strong communication skills and the ability to interface with the Food and Drug Administration (FDA) or Notified Bodies. Ability to interact with Senior Management and provide project updates in a timely manner. Ability to provide multiple project oversite. Preferred: Experience working in manufacturing environment, preferably within the Medical Device Industry. Master's degree in Mechanical, Electrical, Biomedical, Quality Engineering or other life science-based degree are a plus! Quality Certifications from ASQ: CRE, CQE or CQA. FPx Project Management Training. Other: English and additional languages will also be considered at the time of the review. This position is based in Irvine, CA and up to 20% Domestic Travel may be required. A valid drivers or ability to obtain one at time of hire. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-California-Irvine-31 Technology Dr Organization Biosense Webster Inc. (6010) Job Function Engineering Requisition ID 2105928899W

Keywords: Johnson & Johnson, Irvine , Principal Quality Engineer, New Product Development, Other , Irvine, California

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