Responsible for Research project planning, routine surveillance, tracking and reporting with regards to biological evaluation, toxicological risk assessment, and chemical characterization. Serves as subject matter expert and scientific advisor to R&D, Operations, Marketing, Sales, Clinical Affairs, Regulatory (list is not exhaustive). Acts as scientific liaison between external key opinion holders and Zimmer Biomet. Collaborates in project work with departments like process engineering, manufacturing, quality and regulatory as well as with other Zimmer Biomet sites, e and external suppliers (list is not exhaustive). Supports Complaints investigations and other Biomaterials-related Research projects as required.
Principal Duties and Responsibilities
Biocompatibility assessment and organization of respective testing for medical devices
Resource for biological evaluation issues for current manufacturing facilities and 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.
Provide medical and scientific expertise to the global marketing team, global sales team and to the medical information team.
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, toxicological 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.
Demonstrated ability to author Biological Safety Assessments in accordance with ISO10993-1
Working knowledge of analytical chemistry
Has a comprehensive record of external and internal training in area of competence
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
Minimum educational requirement is a MS (PhD degree preferred) in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology.
7+ years experience in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field required
Up to 20%