Senior Laboratory Technician, Biocompatibility Testing

Edwards Lifesciences • Irvine, CA

5d • Onsite

About The Position

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. This is an onsite position at our corporate Irvine, CA campus. Work schedule is Monday - Friday, with overtime or occasional weekend hours as required based on testing volume and deadlines. The Senior Lab Technician will conduct in vivo 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.

Requirements

• Associate's degree in related scientific field (Biology, Veterinary Science, Animal Science, or similar).
• At least three (3) years relative experience with in vivo biological testing and processes within an academic or industry setting (i.e. medical device/pharmaceutical/biotech).

Nice To Haves

• Bachelor’s degree in biology or related scientific field.
• Experience with in-vivo testing within the medical device industry.
• Hands-on experience working with small laboratory animals in a research, academic, biomedical, pharmaceutical, biotechnology, or medical device environment, including activities such as animal handling, dosing/injections, blood collection, health assessments, husbandry, study support, and sample collection.
• An understanding of ISO 10993 testing requirements with hands on testing experience in biocompatibility test methodologies.
• In-depth knowledge of GLP (Good Laboratory Practices), GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) supporting a medical device environment.
• RVT (Registered Veterinary Technician) and /or LAT (Laboratory Animal Technician) certifications.
• Experience with ISO/USP/ASTM biocompatibility evaluation requirements.
• Substantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations.
• Knowledge of AALAS (American Association for Laboratory Animal Science) regulations.
• Good written and verbal communication, interpersonal, and relationship building skills and ability to read, comprehend, write and speak English.

Responsibilities

• Perform and support in vivo testing and operational activities to evaluate biocompatibility and biological safety.
• Execute in vivo studies using small animals, including mouse systemic toxicity, rabbit intracutaneous reactivity, and guinea pig maximization tests.
• Responsible for animal dosing, health assessments, test sample preparation, and adherence to study protocols and laboratory procedures.
• Collect and organize study data files and records.
• Maintains instruments and pieces of equipment in accordance with manufacturers or in-house preventative maintenance and calibration/validation procedures.
• Maintains 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 safety.
• Manage the laboratory’s inventory for glassware, chemicals, reagents and other supplies by ordering, receiving and storing.
• Execute equipment and method validation protocols with minimal supervision.
• Lead small continuous improvement projects.
• May train, coach, and guide lower-level technicians on new procedures, assess work techniques and provide feedback on procedures.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs.
• Initiate and support laboratory investigations and propose recommendations for manager view.
• On-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).

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree