Senior Principal Microbiologist - Critical Care

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.Appendix:On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bdHow you will make an impact: Serve as a GLP study director managing in vitro and in vivo biocompatibility safety studies intended to support all Edwards business units by planning, oversight, execution, and closure of in-house in vitro and in vivo biocompatibility GLP studies including Cytotoxicity (Medium Eluate Method), Hemolysis, Sensitization (Guinea Pig Maximization Test), Irritation (Rabbit Intracutaneous Reactivity Test), Systemic Toxicity (Acute Mouse Systemic Injection), Genotoxicity (AMES, MNvit), and Hemocompatibility (Complement Activation, PTT, PLC) and Coordinate different testing to be performed at contract research organizations (CROs). Provide technical support to all Edwards R&D teams for the qualification of new or modified devices and processes. Collaborate with R&D team to evaluate GLP documents required for biocompatibility studies. Perform assessment of updated standards (ISO, ASTM, OECD) and represent Critical Care in different technical committees. Write and approve protocols, reports, out of specification (OOS) documents, technical summaries, procedures, and gap assessments. Ensure audit findings from the Quality Assurance Unit (QAU) are properly addressed with effective corrective actions and carefully assessed for their impact on the quality or integrity of the study. Address questions from regulatory agencies deficiency letters both domestically and internationally. Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ). Support continuous improvement initiatives by exploring alternate biocompatibility methods and developing new processes with focus on quality and regulatory compliance. Train, coach, and guide lower-level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and proceduresWhat you'll need (Required): Bachelor's Degree in Biology or related field, plus minimum ten (10) years relative experience Master's Degree in Biology or related field, plus minimum eight (8) years of relative experience Ph.D. in Biology or related field , plus minimum six (6) years related experienceWhat else we look for (Preferred): Professional experience as a Sr Study Director or SME Scientist in the medical device or research industry Proven subject matter expert knowledge and understanding of biology principles, theories and concepts, specifically biocompatibility concepts per ISO 10993 standard Expert knowledge of laboratory equipment (e.g., microscope, spectrophotometer, flow cytometer, analytical balance, centrifuge) Extensive knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT) Experienced in project management and presentations to Sr Stakeholders Excellent problem-solving, analytical and critical thinking skills Demonstrates professional communication and interpersonal relationship skills including relationship management skills with ability to influence change and drive achievement of objectives Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint Ability to manage confidential information with discretion Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment Thrives in a collaborative team environment, including representing organization as key technical contact on contracts and projects Ability to interact with senior external representatives (e.g., regulatory agencies, FDA, DEKRA, TUV, MHLW) on significant technical matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $133,000 to $187,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.