Director of Tissue Product Development Lead

4 weeks ago


San Antonio, Texas, United States Extremity Care Full time
Job Description

At Extremity Care, we are seeking a highly skilled and experienced professional to lead our tissue product development initiatives. The Director of Tissue Product Development will be responsible for driving our product strategy, overseeing design and implementation of new products, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Product Strategy: Develop and execute comprehensive strategies for research and new product development in alignment with our business objectives.
  • Regulatory Compliance: Ensure compliance with quality, regulatory, and safety standards, including FDA regulations and AATB standards.
  • Project Management: Establish and maintain engineering and project management procedures, including design control processes.
  • Collaboration: Collaborate closely with the regulatory affairs team to develop regulatory strategies for NPD, and work with marketing and sales teams on go-to-market strategies for new products.
  • Leadership: Lead and develop project management activities, project schedules, budgets, and deliverables, and manage direct reports.
Requirements
  • Education: Bachelor's degree/Master's degree in biomedical engineering, tissue engineering, or mechanical engineering from an accredited college or university.
  • Experience: 8-10+ years of experience in product development or a related field, with 5+ years of leadership experience.
  • Skills: Extensive knowledge of applicable government regulations, ISO, ASTM, and AAMI guidance and standards, and proficiency in project management.

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