Technical Director

Company: Xstrahl
Location: Suwanee
Posted on: February 23, 2021

Job Description:

Xstrahl is a medical technology company that designs clinical and research systems to help eradicate cancer. For more than 20 years, Xstrahl has been shaping the development of superficial and orthovoltage therapies for cancer treatment and advancing pre-clinical research. Xstrahl systems are in operation at more than 700 treatment and research facilities worldwide.

With recent growth, we are looking to hire a Technical Director to join our Suwanee, GA team. The Technical Director is a hands-on leader of the R&D team aligning priorities to ensure projects and routine work are delivered on schedule, meeting functionality/performance/quality and within budget.

The role requires interaction with engineers and managers from other functions on multiple R&D sites and will be responsible for leading the international R&D team, in the areas of Electronics/Software/ Mechanical Technology, Regulatory Compliance- Safety/Risk Control, at a Board and Operational level.

Responsibilities include:

• Hiring and developing personnel, leading a team and managing cross-functional projects.
• Ensuring compliance with the Quality Management System.
• Improving R&D team productivity by managing and reducing time to market while maximizing the utilization of our global resources.
• Developing highly reliable equipment for medical systems/devices.
• Implementation and development of the R&D roadmap.
• Implementation of technologies required to build, update and maintain product development.
• Contributing innovative ideas and leading solutions
• Collaboration with customers and certainly with product line mangers to understand their needs and requirements, assess the product usability in the field, educate them on the product
• Identify and drive process improvements / simplification and commonality, across sites.
• Utilize risk management techniques and requirements tools.
• Drive change with process owners to improve efficiency and reduce cost/overhead.
• Ensuring sufficient understanding of how the product integrates into the customer environment, is used by the customer and how it creates value.
• Direct R&D and documentation in accordance with Xstrahl QMS procedures, international standards, and FDA regulations
• Analyze user needs to determine feasibility of design within time and cost constraints.
  Required Skills and Education:
  
  
  • 5+ years of experience in R&D and people management.
  • 5+ years in a medical system/device development.
  • Experience in defining, developing and delivering projects.
  • Demonstrate leadership, decision making, management, problem-solving, and analytical skills
  • Demonstrate the ability to influence others.
  • Experience of project disciplines combining Research, Business Development, Service, Manufacturing, Regulatory, Marketing, Quality
  • Ability to manage personnel, projects, priorities and workflow in a fast-paced environment.
  • Experience with Agile methodologies
  • Knowledgeable of Regulatory aspects, risk management techniques and procedures eg ISO 14971, FDA guidance, MDD (MDR) and other international standards 13485, 60601-1 -2 -8.
  • Experience of working within a product development quality system
  • Ability to demonstrate a commitment to excellence and high standards.
  • Clear and concise written and oral communication skills.
  • Bachelor of Science or Masters in related field of study
    To be considered you must be able to travel internationally, when Covid safely permits. Also, be able to work flexible hours to accommodate deadlines and colleague in different time zones. And, to take to heart the Xstrahl ethos of- Start, Go, Finish.
    
    Powered by JazzHR
    
    pprrgQaIDk

Keywords: Xstrahl, Roswell , Technical Director, Executive , Suwanee, Georgia