Sr. Biocompatibility Scientist

Job Description Summary

We areseekingan experienced, high caliber Scientist II who will make an important contribution to patient safety by supporting projectsandprogramsrelated tothebiocompatibility of medical devices, materials, and processes. This role willbe responsible forsubmittingtest devicestolaboratories,managingtest progress, and serving as the primary contact for the labs.The Scientist IIwillworkcloselywithcross-functionalteamstoprovidebiocompatibilitydeliverables(biocompatibility plans/reports/justifications)incompliancewithglobalregulatoryrequirementssuchasISO10993.Therolerequirescomprehensiveknowledgeof the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidanceaffectingassigned devices (Class I to Class III).The candidate mustbe able tosupportthebiocompatibilityteamincorrectlyapplyregulatoryrequirementsasappropriatetoproductdevelopmentandchangeactivitiesforassigneddevices.The candidatemusthavestrongability to interpret biological test results and detailed scientific information.

EssentialResponsibilities:

• Developtechnicallysoundprotocols,reports,andregulatorysummariesincollaborationwithcross-functionalprogramteams,testlaboratories,andsuppliers.

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

• Understandbiocompatibilitystrategiesthataddressgapsinmaterials,designandprocessestoachieveoptimalsolutionsthatsatisfycostandtechnicalrequirementsrelated tobiological safety.

• Monitorbiocompatibilitytestingactivitiestoensurethatstudiesareconductedaccordingtothestudyprotocols,SOPs,applicableregulationsandtheprinciplesofGoodLaboratoryPractices(GLP).

• Makepositivecontributionstoandrecommendapproachesforupdatinganddevelopingproceduresforinternalandexternalguidancedocumentsrelatedtobiocompatibility,in compliance with applicable global regulatory requirements (e.g.FDA, ISO, MHLW, and CFDA).

• Assistthebiocompatibilityteammembersinidentifyingcriticalprocessfactorsandtheireffectsonbiologicalsafety.

• Supportbiologicalhazardsriskanalysisactivities.

• Interfacewithkeybusinesspartnersinternallyandexternally.

• Analyze,interpret,anddrawconclusionsfrombiocompatibilitytesting,including,butnotlimitedto,extractableandleachablechemicalcharacterizationandbiologicalevaluations.

• Assistbiocompatibilityteammembersindevelopingstrategiesanddraftingresponsestoregulatorysubmissionquestions relatedtobiocompatibility.

Required Qualifications:

• Associates Degree((± 13 years)

• Minimum 4years 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 withexpertisein 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 assessmentmethodology.

• 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 deadlinesin 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.