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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. 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 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. 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 awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.

What You Can Expect

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. Applies subject matter expertise to solve complex biocompatibility-related problems utilizing technical experience and independent judgment.

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 areas.

How You'll Create Impact

Conduct biological safety risk assessments and develop testing strategies for medical devices.

· Identify and close gaps to meet the regulatory requirements related to biocompatibility in Japan, EU and other regions.

· Complete biological safety risk assessments in accordance with ISO 10993 to support submissions.

· Perform biological safety risk assessment for changes related to supplier and process changes.

· Act as subject matter expert during internal and external audits.

· Analyze biocompatibility test results to determine adequacy of data to meet requirements and apply problem solving skills to troubleshoot unexpected results.

· Help to develop and generate support material for staff training and data presentations.

· 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 standards.

· Educate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterizations.

· Maintain relevant scientific and medical knowledge by attending courses, conferences, and/or meetings.

· Perform Standard assessments, delta analyses and assess the impact of changes on current processes and specifications.

· Monitor and review technical and medical literature.

· Write test protocols, technical reports and perform statistical data analysis.

· Support the manufacturing, sourcing and supplier quality departments in their projects and supplier interactions.

· Communicate with vendors, suppliers, test laboratory engineers, outside consultants and outside researchers.

What Makes You Stand Out

Strong problem-solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.

· Is professional, concise, and sensitive in accomplishing objectives. Demonstrates negotiating skills to effectively manage resources, timelines, problem resolution etc. Ability to find acceptable compromises among different stakeholders even during disagreements.

· Demonstrates strong written and verbal communication skills, being comfortable to make technical presentations to internal and external audiences.

· Plans projects in a systematic way, identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic timelines.

Your Background

Minimum educational requirement is a bachelor’s degree in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, material science and/or toxicology. A master’s degree or PhD is preferred.

· 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 consideration.

· Knowledge of material characterization and biological evaluation per ISO 10993 and risk management per ISO 14971.

· Knowledge in performing toxicological safety risk assessment.

· Basic knowledge of metals, ceramic and/or polymer material and surface modifications (e.g. hydroxyapatite, titanium) properties for medical devices.

· Knowledge of material science (particularly physico-chemical properties of engineering materials and biomaterials).

· Experience in performing chemical characterization studies per ISO 10993-18.

· Familiar with the concept of worst-case assessment.

· Experienced in performing literature studies and statistical data analysis.

· Experienced in writing technical protocols and reports.

· Familiar with regulatory requirements for permanent implants and surgical instruments (in particular materials related requirements).

Travel Expectations

EOE/M/F/Vet/Disability