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Biocompatibility Program Manager
Marmon Holdings, Inc.Biocompatibility Program Manager responsible for biocompatibility program regulations and training across Acumed. Ensure products meet safety standards and manage reporting to executive teams.
About the role
Key responsibilities & impact- Establish and direct all aspects of the biocompatibility (“biocomp”) program for Acumed
- Ensure all products released and in the field are in compliance with current biocompatibility standards
- Work cross-functionally with each business unit to ensure biocomp principles are appropriately applied to new product development
- Provide appropriate training and guidance and review and approve final biocomp documentation
- Manage and report on the status of biocomp initiatives to management teams, including the executive team
- Communicate technical principles related to biocomp effectively and influence key stakeholders internally and externally
- Author, review and approve biocomp evaluation plans, test reports, and final biocompatibility reports
- Use project management tools to manage biocompatibility program initiatives
- Create and train others on work practices in compliance with applicable ISO and CFR regulations/guidance
- Independently manage external vendors and consultants (i.e., toxicologist, test houses, etc.)
- Support new product development across all business units for biocompatibility compliance
Requirements
What you’ll need- Bachelor’s degree in biological or physical sciences, or engineering
- Minimum 5 years of experience applying biocompatibility (surgically invasive and implantable) principles
- Proficiency in Project Management for organizing and managing deliverables
- Strong technical writing, verbal, and interpersonal communication skills
- Proficiency of testing methods (bioburden, Cytotoxicity, Irritation, Extractable/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
Benefits
Comp & perks- Diverse learning and working opportunities
- Positive impact on the world
- Empowered work culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biocompatibilitybiocompatibility testing methodsbioburden testingCytotoxicity testingIrritation testingExtractable/Leachable testingSensitization testingstatistical modelstechnical writingproject management
Soft Skills
interpersonal communicationverbal communicationinfluencing stakeholderstraining and guidancecross-functional collaborationreportingdocumentation reviewindependent management
Certifications
Bachelor’s degree in biological sciencesBachelor’s degree in physical sciencesBachelor’s degree in engineering