Biosense Webster is recruiting for a Staff Quality Engineer, 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. 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.
The Staff Engineer will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster and provides advice and mentorship to less experienced personnel. The successful candidate will be working within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch. The candidate will work closely with members of the project core team (R&D, Product Management, Marketing, Finance, Sourcing, Plan, External Manufacturers etc.,) to define user needs, generate design concepts and prototypes, perform quality control evaluations and support development of product and process validation plans and testing. The candidate will also be involved in test method development and evaluation of the proposed design.
The Staff Quality Engineer will prepare, conduct, monitor and report on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
The Staff Quality Engineer will be responsible for:
- Developing standard operating procedures, specifications, and providing technical transfer and validation support.
Minimizing sample and scrap waste, assessing reliability and risks based on validated data, identifying root causes of problems, and reducing or eliminating sources of variation.
Auditing and approving manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures.
Providing data and documentation in support of the development of validation strategies.
Acting as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products.
Providing sampling plans and approving inspection methods for evaluation and testing of components and products.
Providing support and expertise in reliability planning and reliability growth demonstration during new product development.
Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Bachelor's degree in an engineering discipline, preferably Quality Engineering experience is required.
- Minimum 6 years of engineering experience with a BS, or 4 years with MS in engineering is required.
- Minimum 5 years’ experience in a Quality Engineering environment is required
- Experience working in highly regulated industry is required: working in medical device is preferred.
- Experience working with an integrated cross-functional new product development team is preferred.
A Green/Black Belt Certification is preferred
Experience managing outside vendors and suppliers is preferred
Experience solving technical manufacturing issues is preferredProficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in Quality Control/Management processes is preferred.
Strong technical communication and negotiation skills and demonstrated ability to work independently with external suppliers is required.
Ability to travel up to 10% domestic and international is required
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.
Biosense Webster Inc. (6010)