Head of Programme Management

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.
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.
Uses project management tools to manage biocompatibility program initiatives.
Remains current with biocompatibility standards, testing and regulatory interpretations in the medical device industry.
Applies appropriate testing methods for biocomp evaluations (i.e., Apply appropriate statistical principles to biocomp testing and analysis.
Utilizes knowledge of Acumed products and their indications and method of use to evaluate biological indicators and risks.
Independently manages external vendors and consultants (i.e., toxicologist, test houses, etc.)
Understands and utilizes Acumed project funding processes to manages all aspects of biocompatibility budget (planning process, budget levels and spend, etc.)
Participates as a member of technical review boards for applicable projects/expertise.
Interfaces and collaborates with department leaders to influence and help shape Company strategic initiatives related to biocomp.
Supports new product development across all business units for biocompatibility compliance.
Work within engineering systems, including SAP, CAD, Windchill to perform job functions and document results.
Completes the duties described in the Quality Manual.
Bachelor's degree in biological or physical sciences, or engineering
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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