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.
Other Essential Duties:
Lead smaller process improvement projects (e.g., BEST, Lean) and propose recommendations for manager approval.
Develop non-routine protocols, reports, and methods in collaboration with inter-departmental teams.
Investigate and perform lab and manufacturing 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.
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 Corp