What You Can Expect

This position is responsible for planning, organizing, and conducting biological safety risk assessments on medical devices in accordance with current regulations. Frequent communication with internal and external customers is expected. Both teamwork and individual contributions are valued.

How You'll Create Impact

• Biological Safety Risk Assessments and development of testing strategies for medical devices
• Resource for biological evaluation of changes to current manufacturing processes as well as new manufacturing processes for new product development
• Internal technical document creation and approval
• Support complaints investigations, CAPAs, and other general technical support duties required within the team
• Create Technical Reviews, specifications and other mandatory documents for regulatory submissions
• Review and preparation of procedures to keep pace with standards development
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
• Help to develop and generate material for staff training and data presentations
• Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
• Educate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.
• Provides support for key opinion leaders

What Makes You Stand Out

• Has shown outstanding competencies as subject matter expert
  • In depth knowledge of ISO 10993 standards and EU MDR
  • Working knowledge of analytical chemistry
  • Has a comprehensive record of external training in area of competence
  • Prior experience with risk assessment of manufacturing materials
• Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.
• Has experience in conveying complex scientific topics in a clear and comprehensible fashion.
• Able to effectively resolve conflict between two or more parties
• Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
• Goes beyond existing knowledge base and expands our understanding, methods, and procedures, leaving a base for others to utilize and build upon (trailblazing)
• Demonstrates ability to balance needs of all departments to meet customer expectations and project schedules
• Demonstrates an ability to utilize resources efficiently
• Demonstrated ability to represent the company to accomplish objectives even during disagreements
• Is professional, concise, and sensitive in accomplishing objectives. Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable
• Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
• Handles discussions of complex topics with confidence
• Demonstrates ability to discuss sensitive information with and tailor communication style to listeners’ perspectives, including management, surgeons, and external contacts
• Shows leadership skills and initiative

Your Background

• Minimum educational requirement is a MS in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology.
• Minimum of 4 years experience in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field required