Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. 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.

Principal Duties and Responsibilities

• 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 • Resource for remediation of the biological evaluation of existing product to new regulatory requirements • 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

Expected Areas of Competence

• 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

Education/Experience Requirements

• Minimum educational requirement is a MS in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology. • Minimum of 8 years of experience in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field (such as another regulated industry – pharmaceuticals, food, cosmetics) required. • Minimum of 4 years of experience conducting Biological Safety Assessments per ISO 10993

Travel Requirements

20%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays. EOE/M/W/Vet/Disability