At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance We are committed to creating an environment where every team member feels included, respected, empowered, and
What You Can Expect
Responsible for planning, organizing, and conducting biological safety risk assessments on medical devices in accordance with current Frequent communication with internal and external customers is Applies subject matter expertise to solve complex biocompatibility-related problems utilizing technical experience and independent
Will work in a matrix/cross functional international environment and be responsible for acting as a primary liaison in the communication between Research, Development, Quality, Regulatory Affairs and operations overseeing all relevant standards, updating related processes and documentation related to the implementation of the regulatory requirements in research related
How You'll Create Impact
Conduct biological safety risk assessments and develop testing strategies for medical
• Identify and close gaps to meet the regulatory requirements related to biocompatibility in Japan, EU and other
• Complete biological safety risk assessments in accordance with ISO 10993 to support
• Perform biological safety risk assessment for changes related to supplier and process
• Act as subject matter expert during internal and external
• Analyze biocompatibility test results to determine adequacy of data to meet requirements and apply problem solving skills to troubleshoot unexpected
• Help to develop and generate support material for staff training and data
• Develop and implement biocompatibility testing and rationales to ensure safe and effective performance of products as well as optimization and implementation of new and revised
• Educate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical
• Maintain relevant scientific and medical knowledge by attending courses, conferences, and/or
• Perform Standard assessments, delta analyses and assess the impact of changes on current processes and
• Monitor and review technical and medical
• Write test protocols, technical reports and perform statistical data
• Support the manufacturing, sourcing and supplier quality departments in their projects and supplier
• Communicate with vendors, suppliers, test laboratory engineers, outside consultants and outside
What Makes You Stand Out
Strong problem-solving Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely
• Is professional, concise, and sensitive in accomplishing Demonstrates negotiating skills to effectively manage resources, timelines, problem resolution Ability to find acceptable compromises among different stakeholders even during
• Demonstrates strong written and verbal communication skills, being comfortable to make technical presentations to internal and external
• Plans projects in a systematic way, identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic
Your Background
Minimum educational requirement is a bachelor's degree in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, material science and/or A master's degree or PhD is
• Experience in medical device industry (>2 years) with a demonstrated ability to apply sound
engineering/scientific principles in the performance of research projects and cross-functional project support, relevant doctoral/post doc experience or other relevant industry experience may be taken into
• Knowledge of material characterization and biological evaluation per ISO 10993 and risk management per ISO
• Knowledge in performing toxicological safety risk
• Basic knowledge of metals, ceramic and/or polymer material and surface modifications ( hydroxyapatite, titanium) properties for medical
• Knowledge of material science (particularly physico-chemical properties of engineering materials and biomaterials).
• Experience in performing chemical characterization studies per ISO
• Familiar with the concept of worst-case
• Experienced in performing literature studies and statistical data
• Experienced in writing technical protocols and
• Familiar with regulatory requirements for permanent implants and surgical instruments (in particular materials related requirements).
Travel Expectations
EOE/M/F/Vet/Disability