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Director of Product Development (Cardiovascular/Class III/IIB Devices)–Top$
Durham, NC 27517 United States
Company is nearing the commercialization of multiple cutting-edge, polymer-coated, catheter-based products in the cardiovascular space. Industry interest is high, and it is essential that the right people are in place to drive the development (to approval) efforts. Seek a highly skilled, knowledgeable and “make-things-happen” leader who can step right in. One who will work exceedingly well in an emerging business setting.
Launch experience will be important. Keen understanding of Regulatory requirements and practices will be critical.
Key things to note:
? This is a young company with multiple launches planned. Emerging company bkgd is preferred
? This is a high profile role with extensive interface with executives and board members. Right candidate will be persuasive and effective in this high expectations setting
? This Director will supervise two directly, and lead a large cross-functional team. Seek a superb Project Leader and communicator
? This is a strategic and tactical role. Right candidate will demonstrate a comprehensive understanding of the medical device development cycle as well as the ability to develop smart strategies and tactics that will move products towards approval and, in a hands-on manner, oversee cross-functional teams to ensure the plans are effectively implemented.
This is a critical role and company will pay top dollar, including relo, to attract and retain an industry star.
? Direct the efforts of internal and external cross-functional teams to ensure that all stakeholders understand and effectively comply with development plan procedures, timelines and documentation requirements
? Develop sound, data-based recommendations to enable the execution of project plans, the finalization of product and process design, and strategic decision-making
? Implement company-wide go-to-market plans, and work with all departments to execute
? Oversee the development of methods and systems for the production and testing of new process parameters, technologies and products
? Collaborate with and manage relationships with outside vendors, consultants and universities to support product development and testing, and establish new relationships with outside experts
? Participate in product scale-up, process optimization, technology transfer and process validation activities
? Ensure documentation and procedures comply with regulatory, scientific and legislative standards; write SOPs, protocols, and technical reports.
? Maintain current knowledge of competitive products and their capabilities, and work with industry groups to understand market trends that might affect opportunities and market
? Hire, manage and develop departmental personnel
Targeted candidate will offer an Engineering or Scientific degree and 15+ years of Product Development experience, including 5+ years in a leadership role. Broad and deep understanding of regulatory requirements and practices (CDER and CDRH) related to moving medical device products towards approval will be essential. Other priorities include:
? PMA/IDE/Class III devices expertise
? Experience in interventional cardiology, specifically DES a strong plus
? Extensive experience with Design Control (DC), Product Development Process (PDP), Production Protocol writing, Process Optimization and Scale Up
? Proficiency in design control to support US Regulatory approval as well as Europe and ROW
? Exceptional ability to present to executive leadership team
? Experience directing and overseeing the work done by external suppliers and cross-functional groups.
? Longevity and impact in previous positions
Finally and critically, we seek candidates whose impressive technical credentials are complemented by a track record of successful Product Leadership. Seek candidates with a hands-on, make-things-happen leadership style, astute and adaptive project and people management skills as well as persuasive and adept communicative styles.
This is a Direct Hire opportunity and an immediate need. Please forward Word resume for prompt consideration.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
North Carolina Biotechnology Center