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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.

Duties/Responsibilities

• Works independently and on cross-functional teams in a matrixed environment. 
• Communicates technical principles related to biocomp effectively and influences key stakeholders internally and externally. 
• Authors, reviews and approves biocomp evaluation plans, test reports, and final biocompatibility reports. 
• Responsible for presenting biocomp program updates to large audiences, including the Executive Team 
• Uses project management tools to manage biocompatibility program initiatives. 
• Remains current with biocompatibility standards, testing and regulatory interpretations in the medical device industry.  
• Creates and trains others on work practices in compliance with applicable ISO and CFR regulations/guidance. 
• Applies appropriate testing methods for biocomp evaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.) 
• 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. 
• Follows and works within Acumed’s Design 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 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 

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.