Job ScopeTheBiocompatibility Program Manageris responsible forestablishingand directing all aspects of the biocompatibility(
biocomp
)program forAcumed(
theCompany
).. This individual will ensure all products released and in the fieldare in compliance withcurrent biocompatibility standards for safe use of products inpatients. This individual will work cross functionally with each business unit to ensurebiocompprinciples are appropriately applied to new product development.This individual will ensuretheorganization understandstheimportance ofbiocompprinciples and procedures, provideappropriate training,guidance,andwillreview and approve finalbiocompdocumentation.This individual will manage and report onthestatus ofbiocompinitiatives to management teams, includingtheexecutive teamon a periodic basis. This individualwillwork within a matrixed organization, and may directly manage others on the biocompatibility team.

Duties/Responsibilities

• Worksindependently andoncross-functionalteamsin a matrixed environment.
• Communicatestechnical principles related tobiocompeffectivelyandinfluenceskey stakeholders internally and externally.
• Authors, reviewsand approvesbiocompevaluation plans,test reports,andfinal biocompatibility reports.
• Responsible for presentingbiocompprogram updatesto large audiences, includingthe Executive Team
• Usesproject management tools to manage biocompatibility program initiatives.
• Remainscurrent with biocompatibility standards,testingand regulatory interpretations inthemedical deviceindustry.
• Createsand trainsothers onwork practices in compliance with applicable ISO and CFR regulations/guidance.
• Appliesappropriate testingmethods forbiocompevaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.)
• Applyappropriatestatisticalprinciples tobiocomptestingandanalysis.
• Utilizesknowledge ofAcumedproducts andtheirindicationsand method of use to evaluate biological indicators andrisks.
• Independently manages external vendorsand consultants (i.e.,toxicologist, test houses, etc.)
• Understandsand utilizesAcumedproject funding processes tomanages all aspects of biocompatibility budget (planning process, budget levels and spend, etc.)
• Participates as a member of technical review boards for applicable projects/expertise.
• Interfacesand collaborates with department leaders to influence and helpshapeCompanystrategic initiativesrelated tobiocomp.
• Supportsnew product development across all business units for biocompatibility compliance.
• Work withinengineering systems, includingSAP, CAD, Windchillto perform job functions and document results.
• Follows and works withinAcumed
  sDesign Control process and framework.
• Completes the duties described in the Quality Manual.

Qualifications

• Bachelor
  s degree in biological or physical sciences, or engineering
• Preferred: advanced education in toxicology or microbiology
• Minimum 5years ofexperience applying biocompatibility (surgically invasive and implantable) principles.
• Proficiencyin Project Management for organizing and managing deliverables.
• Ability to multitask and prioritize projects that align with departmental and organizationalobjectives.
• Strong technical writing, verbal, and interpersonal communication skills
• Proficiencyof testing methods(bioburden, Cytotoxicity, Irritation, Extractible/Leachable, Sensitization, etc.)
• Working knowledge of statistical modelsand how to apply to test data for biological evaluations.
• Proficiencywith ISO-10993, ISO-14971, FDA and EU-MDR regulations and application to biocompatibility evaluations.
• Familiarity to SAP, Windchill, CAD software