Website Alfred Mann Foundation
Leads the Alfred Mann Foundation in product development and design control toward clinically appropriate and market driven requirements. Leads the process of identification and vetting of new projects. Supports the development of clinical partnerships, and delivery of systems into clinical studies. Manages and directs the organization toward its primary technological objectives, based on long-term and short-term program goals, by performing the following duties personally or through subordinate managers.
Skills, Education, Knowledge and Abilities that are required in order to perform the job:
Leads the Research and Development efforts for implantable medical devices with vision, communication, technical drive, persistence and team building skills necessary to develop these products.
• Build and support an organization responsive to the Foundation’s needs.
• Identify, in cooperation with other senior executives of the company, new business opportunities. Look for efficient ways to leverage current technical know-how and talent to new opportunities; communicate these possibilities to the CEO and other senior executives in the company.
• Leads the vetting of potential new projects as determined by technical viability, scientific soundness, alignment with the Foundation mission, identification of unmet clinical needs, characterization of relevant patient populations, competitive analysis, intellectual property analysis, reimbursement analysis, and business modeling.
• Identify and solve technical problems at the root cause level before these problems impact the schedule.
• Provide guidance on appropriate levels of risk for new product development. Insure high quality documentation as appropriate to support all development efforts consistent with published company guidelines.
• Insures high product quality and reliability for customer acceptance and FDA approvals.
• Follows all projects through the product development lifecycle internally, ensuring scientific soundness and development toward appropriate requirements.
• Supports the Clinical Department in the development of clinical protocols and execution of human clinical studies.
• Supports the conduct of pre-clinical (animal) studies through sound experimental design in support of appropriate data acquisition.
• Acts as the central point of contact for the Foundation in all external communication relevant to scientific and technical issues. Supplies accurate information to external contacts with a vision toward the positive image of the Foundation, while protecting proprietary information.
• Develop industry relationships and partnership alliances for product success.
• Support and encourage a collaborative work environment at all levels within the organization. Provide performance feedback at regular intervals, and conduct annual performance appraisals.
Education and/or Experience:
• Master’s degree in a field of Engineering or equivalent; or 15 + years related experience and/or training; or equivalent combination of education and experience.
• 10 + years in a medical device industry with a successful track record leading Research and Development projects from concept to commercialization.
• Required knowledge of electrical engineering, mechanical engineering, software systems, document control, business operations, business software, policies and procedures.
• Successful team leadership strategies, conflict management, management and supervision of professional and technical personnel, and empowerment strategies.
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