Biocompatibility Program Manager

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

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

TheBiocompatibility Program Manageris responsible forestablishingand directing all aspects of the biocompatibility(“biocomp”)program forAcumed(“theCompany”).. This individual will ensure all products released and in the fieldare in compliance withcurrent biocompatibility standards for safe use of products inpatients. This individual will work cross functionally with each business unit to ensurebiocompprinciples are appropriately applied to new product development.This individual will ensuretheorganization understandstheimportance ofbiocompprinciples and procedures, provideappropriate training,guidance,andwillreview and approve finalbiocompdocumentation.This individual will manage and report onthestatus ofbiocompinitiatives to management teams, includingtheexecutive teamon a periodic basis. This individualwillwork within a matrixed organization, and may directly manage others on the biocompatibility team.

Duties/Responsibilities

• Worksindependently andoncross-functionalteamsin a matrixed environment.
• Communicatestechnical principles related tobiocompeffectivelyandinfluenceskey stakeholders internally and externally.
• Authors, reviewsand approvesbiocompevaluation plans,test reports,andfinal biocompatibility reports.
• Responsible for presentingbiocompprogram updatesto large audiences, includingthe Executive Team
• Usesproject management tools to manage biocompatibility program initiatives.
• Remainscurrent with biocompatibility standards,testingand regulatory interpretations inthemedical deviceindustry.
• Createsand trainsothers onwork practices in compliance with applicable ISO and CFR regulations/guidance.
• Appliesappropriate testingmethods forbiocompevaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.)
• Applyappropriatestatisticalprinciples tobiocomptestingandanalysis.
• Utilizesknowledge ofAcumedproducts andtheirindicationsand method of use to evaluate biological indicators andrisks.
• Independently manages external vendorsand consultants (i.e.,toxicologist, test houses, etc.)
• Understandsand utilizesAcumedproject funding processes tomanages all aspects of biocompatibility budget (planning process, budget levels and spend, etc.)
• Participates as a member of technical review boards for applicable projects/expertise.
• Interfacesand collaborates with department leaders to influence and helpshapeCompanystrategic initiativesrelated tobiocomp.
• Supportsnew product development across all business units for biocompatibility compliance.
• Work withinengineering systems, includingSAP, CAD, Windchillto perform job functions and document results.
• Follows and works withinAcumed’sDesign Control process and framework.
• Completes the duties described in the Quality Manual.

Qualifications

• Bachelor’s degree in biological or physical sciences, or engineering
• Preferred: advanced education in toxicology or microbiology
• Minimum 5years ofexperience applying biocompatibility (surgically invasive and implantable) principles.
• Proficiencyin Project Management for organizing and managing deliverables.
• Ability to multitask and prioritize projects that align with departmental and organizationalobjectives.
• Strong technical writing, verbal, and interpersonal communication skills
• Proficiencyof testing methods(bioburden, Cytotoxicity, Irritation, Extractible/Leachable, Sensitization, etc.)
• Working knowledge of statistical modelsand how to apply to test data for biological evaluations.
• Proficiencywith ISO-10993, ISO-14971, FDA and EU-MDR regulations and application to biocompatibility evaluations.
• Familiarity to SAP, Windchill, CAD software

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.