Biocompatibility Project Coordinator - Medical Devices

Fresenius Kabi USA; Lake Zurich (IL); On-site; USD 75,000 - 80,000; Full time

Benefits offered by this job

401(k) company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi USA seeks an Associate Project Manager to support medical device material qualification activities in the Transfusion and Cell Therapies group. You will coordinate outsourced biocompatibility studies, chemistry assessments, and related activities under guidance from senior staff.

The role involves managing protocols, documentation and risk assessment, ensuring ISO/FDA standards and working with CROs.

Qualifications

• Bachelor’s degree in chemistry, biology, or related discipline required.
• Minimum 3 years in a related role.
• 1 year of project management experience preferred.
• Familiarity with ISO 10993-1 and related parts, USP <87>, <88>, etc.
• Proficient with Outlook, Word, Excel, PowerPoint; good research skills.

Responsibilities

• Coordinate biocompatibility projects and material qualification studies.
• Prepare, review and approve protocols and reports.
• Manage documentation and database of qualification results.
• Coordinate CROs and supplier audits; ensure GLP/compliance.
• Support development and maintenance of processes and policies.

Skills

Project coordination

Communication

Cross-functional collaboration

Office software

Education

Bachelor’s degree in chemistry or related

Tools

Microsoft Office

Job description

Fresenius Kabi USA seeks an Associate Project Manager to support medical device material qualification activities in the Transfusion and Cell Therapies group. You will coordinate outsourced biocompatibility studies, chemistry assessments, and related activities under guidance from senior staff.

The role involves managing protocols, documentation and risk assessment, ensuring ISO/FDA standards and working with CROs.