Team leader/member of cross-functional team(s) encompassing all aspects of product development from concept through post-commercialization review, with an emphasis on the development of drug/device combination products. Emphasis on leading and managing technical aspects of programs in a matrix organization through influence at all levels of the organization.
Summary of Position with General Responsibilities:
• Team leader/member on cross-functional group comprising product development, quality, regulatory, clinical, manufacturing, and marketing to develop, communicate, and measure progress against goals and metrics for program success.
• Oversee technical aspects of product development from the earliest definition of the product concept through commercialization in all global markets.
• Manage technical aspects of project and product cost against budget; reports and advises on recovery plans necessary to achieve budget targets.
• Coordinate with Franchise Leaders and manufacturing to plan and execute transfer of products from design to production.
• Partner with clinical researchers, clinical organization, corporate resources, marketing, and external stakeholders to plan and execute clinical studies for regulatory approval and to support reimbursement.
• Special Projects as assigned.
• BS Mechanical, Biomedical, Chemical, Life Sciences, or Electrical Engineering degree required.
• Minimum of 8 years experience in medical device industry with a BS or, minimum of 6 years relevant experience with MS. Experience must be as a product development team member in the surgical, disposable medical products or related industries with particular experience in products involving complex clinical and regulatory considerations.
• Proven track record in launching medical device products.
• Experience managing outside design partnerships.
• Good verbal and written communication with all levels of division and corporate leadership.
• Knowledge of GMP’s, current FDA Medical Devices legislation and regulations.
• Ability to travel up to 20%
Additional Desirable Qualifications:
• MS Degree or PhD preferred.
C. R. Bard - 16 months ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...