Biocompatibility Program Lead

Marmon Holdings, Inc.; Hillsboro (OR); On-site; USD 120,000 - 180,000; Full time

Job summary

Acumed LLC seeks a Biocompatibility Program Manager to lead the biocompatibility program, ensuring products meet biocompatibility standards for safe patient use. You’ll collaborate across business units, train teams, and approve biocompatibility documentation.

You will manage external vendors, report to executives, and drive projects in a matrixed organization while maintaining ISO 10993 and CFR alignments.

Qualifications

• Bachelor’s degree in biological or physical sciences, or engineering.
• Advanced education in toxicology or microbiology (preferred).
• Minimum 5 years of experience applying biocompatibility principles.
• Proficiency in project management for organizing deliverables.
• Strong technical writing and verbal/interpersonal communication skills.
• Proficiency with biocompatibility testing methods.
• Working knowledge of ISO standards and regulatory frameworks.
• Familiarity with SAP, Windchill, and CAD software.

Responsibilities

• Works independently and on cross-functional teams in a matrixed environment.
• Communicates technical biocompatibility principles to stakeholders internally and externally.
• Authors, reviews, and approves biocomp evaluation plans and reports.
• Presents biocomp program updates to the Executive Team.
• Uses project management tools to manage biocompatibility initiatives.
• Remains current with biocompatibility standards, testing, and regulatory interpretations.
• Creates and trains others on compliant work practices per ISO and CFR.
• Applies testing methods for biocompatibility evaluations (cytotoxicity, irritation, leachable, etc.).
• Assesses biological indicators and risks for Acumed products.
• Manages external vendors and consultants.
• Manages biocompatibility budget and funding processes.
• Participates on technical review boards and influences strategic initiatives.
• Supports new product development for biocompatibility compliance.

Skills

Project Management

Multitasking

Technical writing

Communication skills

Statistical methods

ISO standards

Education

Bachelor’s degree in biological or physical sciences, or engineering

Advanced education in toxicology or microbiology (preferred)

Tools

SAP

Windchill

CAD software

Job description

Acumed LLC seeks a Biocompatibility Program Manager to lead the biocompatibility program, ensuring products meet biocompatibility standards for safe patient use. You’ll collaborate across business units, train teams, and approve biocompatibility documentation.

You will manage external vendors, report to executives, and drive projects in a matrixed organization while maintaining ISO 10993 and CFR alignments.