Biocompatibility Program Lead - Medical Devices

Acumed LLC; Hillsboro (OR); On-site; USD 120,000 - 190,000; Full time

Job summary

Acumed LLC, part of Marmon Holdings and Berkshire Hathaway, seeks a Biocompatibility Program Manager to lead the biocomp program ensuring product safety and regulatory compliance across development and fielded products.

The role involves cross-functional coordination, training, and oversight of biocompatibility documentation, with engagement at management and executive levels. Proficiency in biocompatibility standards and testing methods is essential.

Qualifications

• Bachelor’s degree in biological or physical sciences, or engineering.
• Advanced education in toxicology or microbiology is preferred.
• Minimum 5 years of experience applying biocompatibility principles (surgically invasive and implantable).
• Proficiency in Project Management for organizing and managing deliverables.
• Strong technical writing, verbal and interpersonal communication skills.
• Proficiency with ISO-10993, ISO-14971, FDA and EU-MDR regulations for biocompatibility.

Responsibilities

• Works independently and on cross-functional teams in a matrixed environment.
• Authors, reviews and approves biocomp evaluation plans, test reports, and final biocompatibility reports.
• Presents biocomp program updates to the Executive Team and management.
• Manages external vendors and consultants (toxicologist, test houses, etc.)
• Utilizes Acumed systems like SAP, Windchill, and CAD to document results.

Skills

Project Management

Technical writing

Cross-functional collaboration

Verbal & interpersonal communication

Education

Bachelor’s degree in biological or physical sciences or engineering

Advanced education in toxicology or microbiology (preferred)

Tools

SAP

Windchill

CAD

Job description

Acumed LLC, part of Marmon Holdings and Berkshire Hathaway, seeks a Biocompatibility Program Manager to lead the biocomp program ensuring product safety and regulatory compliance across development and fielded products.

The role involves cross-functional coordination, training, and oversight of biocompatibility documentation, with engagement at management and executive levels. Proficiency in biocompatibility standards and testing methods is essential.