Biocompatibility Program Manager

Marmon Holdings, Inc.•Hillsboro, OR

About The Position

Acumed LLC, a part of Marmon Holdings and backed by Berkshire Hathaway, is seeking a Biocompatibility Program Manager. This role is responsible for establishing and directing all aspects of the biocompatibility program to ensure Acumed products comply with current biocompatibility standards for safe patient use. The manager will collaborate with business units on new product development, ensure understanding and application of biocompatibility principles, provide training, and review/approve documentation. This position involves managing and reporting on biocompatibility initiatives to management, including the executive team, and may involve direct management of a biocompatibility team within a matrixed organization.

Requirements

Bachelor’s degree in biological or physical sciences, or engineering
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.

Nice To Haves

Advanced education in toxicology or microbiology
Familiarity to SAP, Windchill, CAD software

Responsibilities

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.
Independently manages external vendors and consultants (i.e., toxicologist, test houses, etc.).
Understands and utilizes Acumed project funding processes to manages all aspects of biocompatibility budget (planning process, budget levels and spend, etc.).
Participates as a member of technical review boards for applicable projects/expertise.
Interfaces and collaborates with department leaders to influence and help shape Company strategic initiatives related to biocomp.
Supports new product development across all business units for biocompatibility compliance.
Work within engineering systems, including SAP, CAD, Windchill to perform job functions and document results.
Follows and works within Acumed’s Design Control process and framework.
Completes the duties described in the Quality Manual.