Biocompatibility Program Manager

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

The Biocompatibility Program Manageris responsible forestablishingand directing all aspects of the biocompatibility(“biocomp”)program for Acumed(“the Company”).. This individual will ensure all products released and in the fieldare in compliance with current 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, provide appropriate 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.

• Works independently andoncross-functionalteamsin a matrixed environment.
• Communicatestechnical principles related tobiocompeffectivelyandinfluenceskey stakeholders internally and externally.
• Authors, reviews and approvesbiocompevaluation plans,test reports,andfinal biocompatibility reports.
• Responsible for presentingbiocompprogram updatesto large audiences, including the Executive Team
• Usesproject management tools to manage biocompatibility program initiatives.
• Remains current with biocompatibility standards,testing and regulatory interpretations inthemedical device industry.
• Creates and trainsothers onwork practices in compliance with applicable ISO and CFR regulations/guidance.
• Applies appropriate testing methods forbiocompevaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.)
• Applyappropriatestatisticalprinciples tobiocomptestingandanalysis.
• Utilizes knowledge of Acumedproducts andtheirindicationsand method of use to evaluate biological indicators andrisks.
• Independently manages external vendors and consultants (i.e.,toxicologist, test houses, etc.)
• Understands and utilizes
  
  Acumedproject 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 helpshape
  
  Companystrategic initiatives related tobiocomp.
• Supports new product development across all business units for biocompatibility compliance.
• Work within engineering systems, including SAP, CAD, Windchillto perform job functions and document results.
• Follows and works within
  
  Acumed’sDesign Control process and framework.
• Completes the duties described in the Quality Manual.

• Bachelor’s degree in biological or physical sciences, or engineering
• Preferred: advanced education in toxicology or microbiology
• Minimum 5years of experience applying biocompatibility (surgically invasive and implantable) principles.
• Proficiency in Project Management for organizing and managing deliverables.
• Ability to multitask and prioritize projects that align with departmental and organizational objectives.
• Strong technical writing, verbal, and interpersonal communication skills
• Proficiency of testing methods(bioburden, Cytotoxicity, Irritation, Extractible/Leachable, Sensitization, etc.)
• Working knowledge of statistical…