Hiring company: Edwards Lifesciences
*This position is based at Irvine, CA headquarters and eligible for a comprehensive relocation package
Edwards' Quality Laboratories provides a comprehensive range of testing and consulting services for safety and biocompatibility in order to support preclinical and clinical product development including new product development, manufacturing support, and life cycle management for Edwards Lifesciences' medical devices. This individual will serve as Study Director (e.g., Interpret data and define qualification strategies for new or modified devices and/or processes) and lead in vitro and in vivo biocompatibility studies for new and in-process products including in vitro testing (e.g., cytotoxicity, hemocompatibility, genotoxicity testing) and in vivo testing (e.g., systemic toxicity, intracutaneous reactivity, implantation testing, sensitization testing). Additionally she/he will collaborate with project teams to establish test recommendations and testing in compliance with biocompatibility guidelines by the International Organization for Standardization (ISO), FDA, GLP, MDR, and other national and international standards.
Primary Responsibilities:
• Author, execute, review, and approve biocompatibility protocols and reports.
• Review and interpret test results based on established acceptance criteria for biocompatibility studies.
• Interact with project teams to establish test plans and review supportive documentation and sample quantity.
• Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures.
• Assess internal procedures and processes, as well as perform gap analysis of external standards, as necessary.
• Other incidental duties assigned by Leadership.
Education and Minimum Requirements:
Bachelor's degree in Biology or related field and at least 2 years of relevant experience in biocompatibility and in vitro / in vivo testing within the life sciences industry or at a CRO
OR
Master's degree in biology or related field and at least 1 year of relevant experience in biocompatibility and in vitro / in vivo testing within the life sciences industry or at a CRO
Preferred Qualifications:
Study director experience for class III cardiovascular devices
Additional Talents and General Expectations:
• Proven expertise in MS Office Suite (WORD, Excel, PowerPoint)
• Excellent written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills and strict attention to detail
• Full knowledge in FDA (Food and Drug Administration), and ISO/USP/ASTM biocompatibility evaluation requirements
• Ability to write technical documents and present recommendations to internal and external stakeholders
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) supporting a medical device environment
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• 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 is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.