Principal Quality Engineer, New Product Development
Company: Johnson & Johnson
Posted on: June 9, 2021
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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