MANAGER R&D BALLOON TECHNOLOGY Job in Fremont, California US
Cordis Corporation, a member of Johnson Johnson's Family of Companies, is recruiting for a Manager of RD with Balloon Technology, located in Fremont, CA.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
The Manager, Balloon RD will be responsible for managing the design and development programs for next generation balloon catheter devices used in treatment of cardiovascular disease. This position will manage design teams in conceptualization, design, and development of balloon catheters through commercialization per Quality System Requirements. This position will establish design development plans and budgets and coaches teams to execute aggressively and predictably, identifying and acting upon project risks and opportunities, proactively. The Manager Balloon RD will ensure that user and patient needs are translated through device design requirements, design specifications, and into verified/validated devices and procedures. The Manager Balloon RD will coach teams for preparation and execution of Technical, Peer, and Design Reviews. This role will also be responsible for contributing to the identification of clinical needs, collaborating withMarketing, Clinical, Regulatory, Quality, Manufacturing, etc. to ensure development of innovative and reliable devices that fulfill clinical needs that comply with regulatory requirements, and the generation of Intellectual Property.
The Manager, Balloon RD will supervise engineers and technicians as well as manage development partners and other external vendors to meet project requirements and timelines and perform other duties as assigned.
Qualifications
A Bachelor's Degree in Mechanical Engineering or equivalent is required with a minimum of 3 years of experience managing research and development, product development, or related engineering teams from concept through product commercialization utilizing all phases of Design Control. A minimum 8-10 years of experience in design, development, and commercialization of medical devices, with specific experience in mechanical design, equipment and fixture design for balloon components and balloon catheters is required. Experience managing external partners in development of components for medical devices from concept through commercialization is an additional requirement. The successful candidate will have demonstrated ability to communicate concepts, challenges, and project plans to all levels of the organization, including regular interactions with the executive management board. Prior experience collaborating directly with clinicians to translate clinical, patient, and user needs into validated device designs is required. The successful candidate must have an expertise in design, verification, validation, and commercialization of balloon catheter devices including related equipment and fixtures. Experience with component and assembly manufacturing methods (e.g. molding, machining, sheet metal stamping and forming, laser cutting and welding, extrusion, drawing, bonding, etc.) and direct experience generating and managing detailed project plans and budgets are required. This position requires a strong knowledge of state of the art materials, technologies, and processes used in the design and manufacture of balloon components and balloon catheters. Experience with prototyping and pilot production for balloons components and balloon catheters is required. Proficiency with all common Microsoft programs is strongly recommended. A track record of Intellectual Property generation is an asset for this position.
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