Sr. Biocompatibility Scientist

Job Description Summary  

We are seeking an experienced, high caliber Scientist II who will make an important contribution to patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and processes. This role will be responsible for submitting test devices to laboratories, managing test progress, and serving as the primary contact for the labs. The Scientist II will work closely with cross-functional teams to provide biocompatibility deliverables (biocompatibility plans/reports/justifications) in compliance with global regulatory requirements such as ISO 10993. The role requires comprehensive knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance affecting assigned devices (Class I to Class III). The candidate must be able to support the biocompatibility team in correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. The candidate must have strong ability to interpret biological test results and detailed scientific information. 

Essential Responsibilities: 

• Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers. 

• Support quality system activities, including updating procedures and templates to ensure compliance with regulatory requirements and continuous improvement initiatives. 

• Understand biocompatibility strategies that address gaps in materials, design and processes to achieve optimal solutions that satisfy cost and technical requirements related to biological safety. 

• Monitor biocompatibility testing activities to ensure that studies are conducted according to the study protocols, SOPs, applicable regulations and the principles of Good Laboratory Practices (GLP). 

• Make positive contributions to and recommend approaches for updating and developing procedures for internal and external guidance documents related to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA). 

•  Assist the biocompatibility team members in identifying critical process factors and their effects on biological safety. 

• Support biological hazards risk analysis activities. 

• Interface with key business partners internally and externally. 

• Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations. 

• Assist biocompatibility team members in developing strategies and drafting responses to regulatory submission questions related to biocompatibility. 

Required Qualifications: 

• Associates Degree ((± 13 years)  

• Minimum 4 years experience  

Preferred Qualifications 

• Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or other medical-related disciplines. Master in Science (MS) degree preferred.  

• 3+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields with expertise in biocompatibility, toxicology, and/or special process validation. A master’s degree in a relevant engineering or scientific discipline may substitute for years of industry experience.  

• Fundamental understanding or direct experience with ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.  

• Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive).  

• Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels within the organization.  

• Strong technical writing skills, with experience in writing biological risk assessments for FDA and Notified Bodies preferred.  

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.  

• Ability to prioritize and meet deadlines in a timely manner.  

• Strong organizational and follow-up skills, with attention to detail.  

• Experience working in a broader enterprise/cross-division business unit model preferred.  

• Ability to work in a highly matrixed and geographically diverse business environment.