Edwards Lifesciences Study Director, Preclinical Studies in Irvine, California
This position will serve as Study Director in the Quality Labs department to lead in vitro and in vivo biocompatibility studies for new and in-process products.
Write and approve protocols, reports, out of specification (OOS) documents, technical summaries, procedures, and gap assessments
Types of testing includes in vitro testing (e.g., cytotoxicity, hemocompatibility, genotoxicity, testing) and in vivo testing (e.g., systemic toxicity, irritation/intracutaneous reactivity, implantation testing, sensitization testing)
Interpret data, define qualification strategies for new or modified devices and/or processes
Collaborate with project teams to assist in establishing test recommendations and testing in biocompatibility guidelines by the International Organization for Standardization (ISO) 10993
Lead smaller process improvement projects and propose recommendations for manager approval.
Develop non-routine protocols, reports, and methods in collaboration with inter-departmental teams.
Investigate and perform lab corrective and preventative actions (CAPA).
May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures.
Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ).
Other incidental duties assigned by Leadership.
Education and Minimum Requirements:
Bachelor’s degree in a relevant scientific field, and a minimum of 4 years of industry experience in biocompatibility testing, including in vitro and in vivo; OR Master’s degree in relevant scientific field and 2 years of industry experience in biocompatibility testing, including in vitro and in vivo.
- Prior (ISO) 10993 experience as a pre-clinical site director in the medical device industry
Additional Talents and General Expectations:
Excellent written and verbal communication skills and interpersonal relationship skills.
Demonstrate critical thinking skills.
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 Good Laboratory Practices, Good Manufacturing Practices, 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.
Ability to work independently on more complex projects and/or lines of work and review 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 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 13,000 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.