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Staff Engineer - Materials & Device Engineering - (Job Number: 0806720)
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Country: USA
Location: California-Oakland/East Bay Fremont, CA 94536
Total applied: 40 |
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Staff Engineer - Materials & Device Engineering - (Job Number: 0806720)
Staff Engineer - Materials & Device Engineering - (Job Number: 0806720) DescriptionThis is a product and technology development engineering position based within the front-end Accelerated Medical Ventures (AMV) R&&D organization for Cordis Corporation, a Johnson && Johnson company. Applies intensive and diversified knowledge of Material Science and Mechanical Engineering principles and practices in broad areas of assignments for the development and subsequent commercialization of novel interventional devices. Makes decisions independently and as a part of multi-disciplinary technical teams. Involved in supporting the conceptualization of intravascular devices, systems and enabling technologies such as drug coated stent systems from conception to commercialization, as appropriate. Responsible for supporting innovative development of product and/or corresponding testing concepts based on internal and/or external customer needs. Provide technical support to downstream commercialization teams. When needed, reviews, approves, and/or executes Installation, Operational, and Performance Qualifications validation documentation for various test equipment and related systems. Writes, reviews, and approves documentation for both internal and, as required, for external audiences (e.g. peer-reviewed publications, etc). Responsible for directing and/or interacting with external vendor development activities as well with interorganizational projects that may span the Johnson && Johnson operating group of companies. In a technical leadership capacity as needed, will plan, develop, coordinate, and direct a diverse engineering project. Will be responsible for providing technical leadership and supervisorial guidance to technicians and junior engineers and scientists, as appropriate. BS degree with a minimum of 9 years or MS degree with a minimum of 7 years or a PhD degree with a minimum of 4 years in Material Science and/or Mechanical Engineering. It is also required to have a minimum of 4 years of experience in an FDA regulated environment. Strong material science background in mechanical property characterization, fatigue and relevant process technologies preferred. Knowledge of ISO and cGMP regulations as well as a strong knowledge of and training in Quality Systems Regulations (QSR) are expected. Strong project management and interpersonal influencing skills are required. Strong analytical and communications skills are critical. Ability to effectively present information within a group setting and/or to respond to questions from groups of managers, clients, customers, regulatory agency representatives and/or the general public, when necessary. CAD programming (e.g. AutoCAD/ SolidWorks) experience considered a plus. Problem-solving ability required. Multi-task oriented. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form is required. Ability to use PC's and associated software is required. 20% domestic travel with occasional international travel, as necessary. Apply Now
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