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Director, Biocompatibility & Toxicology

Company: Edwards Lifesciences
Location: Irvine
Posted on: May 3, 2021

Job Description:

Edwards Quality Lab provides a comprehensive range of testing and consulting services for safety and biocompatibility evaluation across a spectrum of our cardiovascular products. The Director, Biocompatibility & Toxicology will oversee preclinical in vivo and in vitro testing laboratories, toxicology, biocompatibility safety assessment and testing of our class II and class III medical devices.KeyResponsibilities:Oversee testing staff and laboratories performing in vivo and in vitro biological testing of primarily class II and III medical devices.Lead Biocompatibility subject matter experts in developing biocompatibility safety testing strategies and providing support to new product development teams and to teams responsible for on-going improvements to commercially marketed medical devices.Oversee Toxicologists performing risk assessments and biological safety assessments.Support new product development teams in developing global strategies for biocompatibility safety assessment and testing.Primary leadership role to drive on-going compliance with international harmonized standards such as ISO 10993-1 and ISO 14971.Education and MinimumRequirements:Bachelor's Degree in Biology, Chemistry or other related scientific degree, and a minimum of 10 15 years of relevant experience in the medical device industry or combination of medical device and pharmaceutical/biotechnology.Extensive knowledge and experience in Biocompatibility assessment, testing and risk evaluation of class II and III medical devices. Strong familiarity with ISO 10993-1 and related 10993 standards, and ISO 14971. People-leadership experience for teams of 3+ direct reports, as well as indirect reportsExcellent understanding of global regulatory requirements related to biocompatibility of medical devices.Preferred QualificationsMaster's or Doctorate degree in Biology, Chemistry or other science degree, related to scope of responsibilities, as described above.Additional Talents and General Expectations:Proven successful project management leadership skillsProven expertise in quality systemsExcellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision makingExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesExpert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problemsExpert understanding of related aspects of quality engineering processes and/or systemsExpert knowledge of company procedures and applicable domestic/international regulations and standardsExpert knowledge of implementation and administration of Quality System processes used in medical device industryDemonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relationsAbility to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the businessServe as core partner to senior leadership in Business Units, Functional Groups, RegionsStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to work and excel within a fast paced, dynamic, and constantly changing work environmentInteracts with senior management, and others concerning matters of significance to the companyConduct business and technical briefings for senior and top management and for external representativesRegularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organizationDedicated to quality client service and pro-active and responsive to client needs.Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.Develop relationships and leverage them to influence changeSupport and solicit input from team members at all levels within the organizationAdhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Full timeSDL2017

Keywords: Edwards Lifesciences, Irvine , Director, Biocompatibility & Toxicology, Other , Irvine, California

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