Biocompatibility Program Lead

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

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.