Warsaw, Indiana

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.

Responsible for Research project planning, executing, and reporting with regards to assessment of manufacturing materials and biological safety of devices as well as cleaning specifications, analytical testing development and biological safety assessments. 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, and external suppliers (list is not exhaustive). Supports Complaints investigations and other Biomaterials-related Research projects as required.

Principal Duties and Responsibilities

• Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR.
• Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO…)
• Write toxicological assessment and biological evaluation reports
• Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner
• Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
• Proactively identify future biological safety challenges and develop strategies to address them
• Review and prepare procedures to keep pace with standards development
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
• Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
• Help to develop and generate material for staff training and data presentations
• Provides support for key opinion leaders

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence

• Has shown outstanding competencies as subject matter expert in the following areas
• Current global toxicological guidelines (USP, JP, Ph., Eur., etc.)
• ISO 10993 standards
• EU MDR requirements
• Risk assessments of manufacturing contact materials
• Working knowledge of analytical chemistry
• Ability to work within a multidisciplinary team setting with good interpersonal skills
• Excellent oral and written communication skills
• 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.
• Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
• 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(PhD degree preferred in Toxicology (DABT certification a plus)
• Minimum of 10 years industrial experience, preferably in implantable medical device industry(orthopedic devices preferred) and/or at contract laboratories.

Travel Requirements

Up to 20%

Additional Information

EOE/M/W/Vet/Disability

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.

Warsaw, Indiana

Zimmer Biomet Team Members share the singular purpose of working to restore mobility and improve the quality of life for patients around the world. With operations around the world, we’re looking for Team Members who would like to make a difference in people’s lives.

We hire talented and highly motivated people with a range of skills, experiences, and backgrounds to fulfill roles in careers such as engineers and clinicians, or in quality and regulatory affairs, manufacturing, marketing, sales, and information technology, to name just a few.

Your chance to push the boundaries of innovation and make a valued contribution to helping people around the world find renewed vitality starts here. If you’d like to learn more about becoming a Zimmer Biomet Team Member, here are some Frequently Asked Questions.

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Recruitment Fraud Alert

Zimmer Biomet is an equal opportunity and affirmative action employer. M/F/Disability/Veteran

Applicants have rights under Federal Employment Laws:  Family and Medical Leave Act (FMLA) PosterEqual Employment Opportunity (EEO) PosterSupplemental Equal Employment Opportunity (EEO) is the Law PosterEmployee Polygraph Protection Act (EPPA) PosterPay Transparency Notice Poster

U.S. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. Zimmer Biomet participates in E-Verify to confirm work authorization. View the E-Verify posters in English or Spanish, as well as the Right to Work poster in English or Spanish.

We invite all interested and qualified candidates to apply for employment opportunities.

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