Biocompatibility Program Lead

Marmon Holdings, Inc.; Hillsboro (OR); On-site; USD 130,000 - 180,000; Full time

Job summary

Acumed LLC, part of Marmon Holdings (backed by Berkshire Hathaway), seeks a Biocompatibility Program Manager to establish and direct all aspects of the biocompatibility program for Acumed. You will ensure products released and in the field comply with current biocompatibility standards and work cross-functionally to apply biocomp principles to new product development.

You will manage and report on biocompatibility initiatives to management, including the Executive Team, in a matrixed

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 principles.
• Proficiency in project management for organizing and managing deliverables.
• Proficiency with ISO-10993, ISO-14971, FDA and EU-MDR regulations and application to biocompatibility evaluations.

Responsibilities

• Works independently and on cross-functional teams in a matrixed environment.
• Communicates technical principles related to biocompatibility effectively and influences key stakeholders internally and externally.
• Authors, reviews and approves biocompatibility evaluation plans, test reports, and final biocompatibility reports.
• Responsible for presenting biocompatibility 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.

Skills

Biocompatibility

Project management

Technical writing

Cross-functional collaboration

Education

BSc in sciences/engineering

Toxicology / microbiology (adv preferred)

Tools

SAP

Windchill

CAD software

Job description

Acumed LLC, part of Marmon Holdings (backed by Berkshire Hathaway), seeks a Biocompatibility Program Manager to establish and direct all aspects of the biocompatibility program for Acumed. You will ensure products released and in the field comply with current biocompatibility standards and work cross-functionally to apply biocomp principles to new product development.

You will manage and report on biocompatibility initiatives to management, including the Executive Team, in a matrixed