This position 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, hemolysis, heparin testing) and in vivo testing (e.g., systemic toxicity, intracutaneous reactivity, implantation testing, sensitization testing). Collaborate with project teams to assist in establishing test recommendations and testing in biocompatibility guidelines by the International Organization for Standardization (ISO) 10993 OR Conduct moderately complex genotoxicity assays (e.g., Ames – Plate Incorporation Test, Chromosomal Aberration, Micronucleus test) utilizing advanced pipetting techniques.
**Education / Requirements / Skills:**
+ Bachelor’s degree in a related field, and a minimum of 4 years of relevant experience in biocompatibility testing, including in vitro and in vivo; OR Master’s degree in related field and 2 years of relevant experience in biocompatibility testing, including in vitro and in vivo.
+ Excellent written and verbal communication skills and interpersonal relationship skills.
+ Demonstrated problem-solving and critical thinking skills.
+ Moderate knowledge and understanding of Edwards policies and procedures relevant to biology.
+ Moderate knowledge and understanding of biology principles, theories and concepts.
+ Excellent written and verbal communications skills.
+ Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
+ Advanced problem-solving skills and strict attention to detail.
+ Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
+ Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
+ Ability to interact professionally with all organizational levels.
+ Ability to manage competing priorities in a fast-paced environment.
+ Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness.
+ 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 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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Study Director, Preclinical Studies
Location: USA-USA-California – Irvine
Job Number: 018785