Senior Laboratory Technician, Biology

Senior Laboratory TechnicianThis is an onsite position at our corporate Irvine, CA campus. Regular schedule hours are M-F daytime, with overtime or occasional weekend hours as required based on testing volume and deadlines.Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Laboratory Technician position is a unique career opportunity that could be your next step towards an exciting future.The Senior Lab Technician will conduct in vitro laboratory testing services within a lab environment with the Edwards Quality Lab (EQL). Will provide a comprehensive range of safety and biocompatibility testing for the evaluation of Edwards medical devices. We are looking for a Laboratory Technician who enjoys being hands on, working in a fast-paced environment, who will take an active role in non-clinical testing to support Edwards manufacturing, new product development, and submission to FDA and other regulatory agencies.How you will make an impact:Perform and/or assist in biology laboratory testing and processes in in vitro area. The tests include cytotoxicity, hemolysis, partial thromboplastin time (PTT), complement activation, and genotoxicity assaysPrepare test samples for routine and qualification testing. Perform the cultivation and maintenance of cell/bacterial cultures as required for any in vitro testingCollect and organize study data files and recordsMaintains instruments and pieces of equipment in accordance with manufacturers' or in-house preventative maintenance and calibration/validation proceduresMaintains laboratory in a safe, clean, and orderly condition, which includes functional checks on laboratory equipment (CO2 incubators, refrigerator/freezer, etc.) and facilitates the storage, collection and disposal of biohazardous or hazardous materials and adheres to regulations relating to health and safetyManage the laboratory's inventory for glassware, chemicals, reagents and other supplies by ordering, receiving and storingExecute equipment and method validation protocols with minimal supervisionLead small continuous improvement projectsMay train, coach, and guide lower-level technicians on new procedures, assess work techniques and provide feedback on proceduresReview, follow and perform job functions in compliance with established work instructions and adherence with SOPsInitiate and support laboratory investigations and propose recommendations for manager viewOn-time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour (or longer work period based on testing volume and key deadlines)What you'll need (Required Qualifications):Associates degree in related science field, plus a minimum of three (3) years relative experience with in vitro and/or in vivo biological testing and processes within an academic or industry setting (i.e. medical device/pharmaceutical/biotech).What else we look for (Preferred Qualifications):Bachelor's degree in biology or related scientific fieldExperience with in-vitro testing within the medical device industryAn understanding of ISO 10993 testing requirements with hands on testing experience in biocompatibility test methodologiesIn-depth knowledge of GLP (Good Laboratory Practices), GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) supporting a medical device environmentExperience with ISO/USP/ASTM biocompatibility evaluation requirementsSubstantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulationsKnowledge of AALAS (American Association for Laboratory Animal Science) regulationsGood written and verbal communication, interpersonal, and relationship building skills and ability to read, comprehend, write and speak EnglishAligning 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 $63,000 to $73,000 (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.