The board
- Hours
- Full time
- Where
- Hillsboro, OR
- Posted
- Sep 2
Acumed LLC
As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.
Job Scope The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility (“biocomp”) program for Acumed (“the Company”).. This individual will ensure all products released and in the field are in compliance with current biocompatibility standards for safe use of products in patients. This individual will work cross functionally with each business unit to ensure biocomp principles are appropriately applied to new product development. This individu…
What you'd do
- Works independently and on cross-functional teams in a matrixed environment.
- Communicates technical principles related to biocomp effectively and influences key stakeholders internally and externally.
- Authors, reviews and approves biocomp evaluation plans, test reports, and final biocompatibility reports.
- Responsible for presenting biocomp 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.
- Applies appropriate testing methods for biocomp evaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.)
- Apply appropriate statistical principles to biocomp testing and analysis.
- Utilizes knowledge of Acumed products and their indications and method of use to evaluate biological indicators and risks.
What they want
- Bachelor’s degree in biological or physical sciences, or engineering
- Preferred: advanced education in toxicology or microbiology
- Minimum 5 years of experience applying biocompatibility (surgically invasive and implantable) principles.
- Proficiency in Project Management for organizing and managing deliverables.
- Ability to multitask and prioritize projects that align with departmental and organizational objectives.
- Strong technical writing, verbal, and interpersonal communication skills
- Proficiency of testing methods (bioburden, Cytotoxicity, Irritation, Extractible/Leachable, Sensitization, etc.)
- Working knowledge of statistical models and how to apply to test data for biological evaluations.
- Proficiency with ISO-10993, ISO-14971, FDA and EU-MDR regulations and application to biocompatibility evaluations.
- Familiarity to SAP, Windchill, CAD software
- Starts
- 2026-04-24