Biocompatibility Program Manager

** Job Scope
** The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility (“biocomp”) program for Acumed (“the Company”)..  This individual will ensure all products released and in the field are in compliance with current biocompatibility standards for safe use of products in patients.  This individual will work cross functionally with each business unit to ensure biocomp principles are appropriately applied to new product development.  

This individual will ensure the organization understands the importance of biocomp principles and procedures, provide appropriate training, guidance, and will review and approve final biocomp documentation.  This individual will manage and report on the status of biocomp initiatives to management teams, including the executive team on a periodic basis.  This individual will work within a matrixed organization, and may directly manage others on the biocompatibility team.

Authors, reviews and approves biocomp evaluation plans, test reports, and final biocompatibility reports.

Uses project management tools to manage biocompatibility program initiatives. current with biocompatibility standards,  knowledge of Understands and utilizes Acumed project funding processes to manages all aspects of biocompatibility budget (planning process, budget levels and spend, etc.) Supports new product development across all business units for biocompatibility compliance.

- Completes the duties described in the Quality Manual.

- Preferred: advanced education in toxicology or microbiology

Minimum 5 years 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 models and how to apply to test data for biological evaluations.

Proficiency with ISO-10993, ISO-14971, FDA and EU-MDR regulations and application to biocompatibility evaluations.

- Familiarity to SAP, Windchill, CAD software

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