Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!What You Can ExpectThis 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 ImpactBiological Safety Risk Assessments and development of testing strategies for medical devicesResource for biological evaluation of changes to current manufacturing processes as well as new manufacturing processes for new product developmentInternal technical document creation and approvalSupport complaints investigations, CAPAs, and other general technical support duties required within the teamCreate Technical Reviews, specifications and other mandatory documents for regulatory submissionsReview and preparation of procedures to keep pace with standards developmentRepresent 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 presentationsMaintain relevant scientific and medical knowledge by attending conferences, courses and meetingsEducate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.Provides support for key opinion leadersWhat Makes You Stand OutHas shown outstanding competencies as subject matter expertIn depth knowledge of ISO 10993 standards and EU MDRWorking knowledge of analytical chemistryHas a comprehensive record of external training in area of competencePrior experience with risk assessment of manufacturing materialsHas 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 partiesStrong problem solving skills.
Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely mannerGoes 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 schedulesDemonstrates an ability to utilize resources efficientlyDemonstrated ability to represent the company to accomplish objectives even during disagreementsIs professional, concise, and sensitive in accomplishing objectives.
Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetableDemonstrates 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 questionsHandles discussions of complex topics with confidenceDemonstrates ability to discuss sensitive information with and tailor communication style to listeners' perspectives, including management, surgeons, and external contactsShows leadership skills and initiativeYour BackgroundMinimum 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 requiredEOE/M/F/Vet/Disability