Biocompatibility Program Manager

Acumed; Addison, Northern (TX, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Acumed is seeking a Biocompatibility Program Manager in Addison, TX to lead the biocompatibility program for medical devices. You will define evaluation plans, review test reports, and ensure compliance with ISO-10993, FDA and EU-MDR while guiding cross-functional teams across development and post-market activities.

You will train staff on biocompatibility practices, manage budgets, and report program status to senior leadership.

Qualifications

• Bachelor’s degree or higher in biological/physical sciences or engineering.
• Advanced studies in toxicology or microbiology preferred.
• Minimum 5 years applying biocompatibility principles to implanted devices.
• Proficient in project management and regulatory usage (ISO 10993, FDA/EU-MDR).

Responsibilities

• Lead biocompatibility program development, evaluation plans and reports.
• Coordinate cross-functional teams and present updates to executives.
• Ensure compliance with ISO 10993, FDA and EU-MDR regulations.
• Manage external vendors, budgets and testing services.
• Collaborate with engineering, QA and R&D across product life cycles.

Skills

Project management

Technical writing

Multitasking

Communication

Statistical methods

Regulatory knowledge

Education

Bachelor’s degree in biological or physical sciences or engineering

Advanced education in toxicology or microbiology

Tools

SAP

Windchill

CAD

Job description

## Biocompatibility Program ManagerApply: Hillsboro, OR: Addison, TX: Full time: Posted 30+ Days Ago: JR0000042582Acumed LLCAs 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.**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 softwareFollowing 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 [e-mail], and please be sure to include the title and the location of the position for which you are applying.