Posted on: February 23, 2021
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.
- Hiring and developing personnel, leading a team and managing
- 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
- Developing highly reliable equipment for medical
- 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
- Ensuring sufficient understanding of how the product integrates
into the customer environment, is used by the customer and how it
- 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
- 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,
- 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
- Ability to demonstrate a commitment to excellence and high
- 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.
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Keywords: Xstrahl, Roswell , Technical Director, Executive , Suwanee, Georgia
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