Biocompatibility Program Manager

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.).
• 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 manage 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