Staff Design Quality Engineer Job in West Chester, Pennsylvania Us
Animas Corporation, a member of Johnson Johnson's Family of Companies, is recruiting for a Staff Design Quality Engineer, located in West Chester, PA.
Animas Corporation, a fully-integrated global company within the Johnson Johnson family of companies, is an innovator in insulin pump technology, with products such as the ground-breaking OneTouch Ping. The company is experiencing an unprecedented period of strong growth, outpacing the rapid market growth in the insulin delivery category. As part of the Johnson Johnson Diabetes Franchise, the company's mission is to create a world without limits for people with diabetes. Animas is dedicated to making diabetes management easier through product innovation, exceptional customer support and customized education programs. Our mission is to improve the lifestyle of our patients, reduce the long-term morbidity of the disease and lower healthcare costs.
The Staff Design Quality Engineer will function as quality lead on Diabetes Care Franchise new product and product change projects related to the insulin delivery portfolio and support electro-mechanical medical devices and non-electro-mechanical accessories. This position is responsible for utilizing effective and efficient Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, and development of sampling plans during product development cycle as well as reliability engineering activities such as developing specifications, driving the requirements, estimating failure rate, developing test plan and protocols and performing failure analysis. A strong understanding of medical device regulations including FDA GMP, design controls, ISO13485, regulatory audits and international environmental regulations is expected to successfully operate in this function. This position will lead and ensure the development of comprehensive risk management plan according to ISO 14971 including design and process FMEAs, and fault tree analysis. The Staff Design Quality Engineer will partner with Operations, RD, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady-state manufacturing. Additionally, this position will provide guidance to project teams and business partners, including external manufacturers and external developers, to ensure compliance with company policies and procedures as well as medical device regulations.
Qualifications
A minimum of a Bachelor's degree in Engineering and 6 years of related work experience is required for this position. Electrical Engineering is highly desired. Demonstrated competency of regulatory requirements such as, FDA QSR's, ISO 13485:2003, Risk Management, and Design Controls is required. Demonstrated competency of statistics, sampling strategies, design of experiments, and structured problem solving methodologies is required. Experience in reliability engineering of hand-held devices highly desired, experience in sterilization is preferred, and knowledge in software validation is an asset for the Staff Design Quality Engineer. This position requires the incumbent to have the ability to work independently with limited direction, partner with appropriate departments, and communicate effectively with all levels in the organization. Six Sigma Green Belt or Black Belt would be a plus for this role, ASQ Certification in Quality Engineering, Software Quality and/or Quality Management is also a preference. The Staff Design Quality Engineer is located in West Chester, PA and requires up to 10% travel.
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