Edwards Lifesciences Director, Biocompatibility & Toxicology in Irvine, California
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.
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 Minimum Requirements :
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 reports
Excellent understanding of global regulatory requirements related to biocompatibility of medical devices.
Master'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 skills
• Proven expertise in quality systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
• Expert understanding of related aspects of quality engineering processes and/or systems
• Expert knowledge of company procedures and applicable domestic/international regulations and standards
• Expert knowledge of implementation and administration of Quality System processes used in medical device industry
• Demonstrated 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 relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business
• Serve as core partner to senior leadership in Business Units, Functional Groups, Regions
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Interacts with senior management, and others concerning matters of significance to the company
• Conduct business and technical briefings for senior and top management and for external representatives
• Regularly 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 organization
• Dedicated 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 change
• Support and solicit input from team members at all levels within the organization
• Adhere 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/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.