Director Product Development

• Select correct design concepts and fundamental technology to meet project needs
• Oversee key projects, processes and performance reports and provide analysis based on available data and reports
• Develop and implement methods and procedures for monitoring the technical component of projects in order to inform management of current status of each project  in relation to budget and timing
• Develop and execute program strategies that successfully fulfill complex design specifications as well as quality and regulatory requirements.
• Manage and lead multidiscipline technical teams through the process of designing and developing electro-mechanical equipment with a high degree of competence and experience.
• Independently contribute/execute tasks associated with the design of electro-mechanical equipment with a high degree of competence and experience (i.e., able to independently contribute [consistent with candidate’s area formal education] to technical deliverables).
• Effectively communicate programmatic strategy, technical deliverables, program status, etc., to both internal and external stakeholders (i.e., client and Ximedica senior management)
• Plan and formulate aspects of research and development proposals such as objective or purpose of project, applications that can be utilized from findings, costs of project, and equipment and human resource requirements

• Excellent verbal and written communication skills with clients and direct reports, colleagues and senior leaders.
• Strong presentation skills.
• Familiarity with the following standards that are integral to formulating and executing medical device development strategies:
  • FDA QSR: 21 CFR 820 Medical Device Quality System Regulation
  • ISO 13485 Medical Device Quality System Management
  • ISO 14971 Medical Device Application of Risk Management
  • ISO 10993 Biological Evaluation of Medical Devices
  • ISO 11607 Packaging for Terminal Sterilized Medical Devices
  • IEC 60601 Medical Equipment Basic Safety & Essential Performance
  • IEC 62304 Medical Device Software Life Cycle

Education and Experience:

• Minimum of Bachelor's degree in an engineering discipline from an accredited College/University (e.g., Product Design, Mechanical, Electrical, Biomedical).
• Ten to fifteen years of experience with the following:
  1. Technical product design and engineering
  2. Technical managerial and mentoring
  3. Programmatic reporting and presentation (both internal and external/client-facing)
  4. Phase driven product development (Concept-to-Market)
  5. Medical device regulated quality environment with verification and validation experience