Biocompatibility Program Manager

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 individual will ensure   the   organization understands   the   importance of   biocomp   principles and procedures, provide   appropriate training ,   guidance ,   and   will   review and approve final   biocomp   documentation.    This individual will manage and report on   the   status of   biocomp   initiatives to management teams, including   the   executive team   on a periodic basis .  This individual   will   work within a matrixed organization , and may directly manage others on the biocompatibility team. Duties/Responsibilities Works independently and on cross-functional teams in a matrixed environment.  Communicates   technical principles related to   biocomp   effectively   and   influence s   key stakeholders internally and externally .   Author s , review s   and approve s   biocomp   e valuation plans,   test reports,   and   final biocompatibility reports.   Responsible for p resent ing   biocomp   program updates   to large audiences, including   the Executive Team   Use s   project management tools to manage biocompatibility program initiatives.   Remain s   current with biocompatibility standards,   testing   and regulatory interpretations in   the   medical device   industry.    C reate s   and train s   others on   work practices in compliance with applicable ISO and CFR regulations/guidance.   Appl ies   appropriate testing   methods for   biocomp   evaluations (i.e., cytotoxicity, sensitization, MMP, Irritation, Extractable / Leachable, etc.)   Apply   appropriate   statistical   principles to   biocomp   testing   and   analysis.   Utilize s   knowledge of   Acume d   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 process es 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 .    Support s   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.   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 (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   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 [email protected], and please be sure to include the title and the location of the position for which you are applying.