Senior Laboratory Technician, Biocompatibility Testing (Animal Studies)

Edwards Lifesciences • Irvine, CA

5d • $53,000 - $75,000 • Onsite

About The Position

The Senior Laboratory Technician conducts in vivo laboratory testing services in a laboratory environment with the Edwards Quality Lab (EQL). The role provides safety and biocompatibility testing to evaluate Edwards medical devices and supports manufacturing, new product development, and submissions to the FDA and other regulatory agencies. This is an onsite position at Edwards’ corporate campus in Irvine, California, with a Monday–Friday schedule and overtime or occasional weekend hours as required by testing volume and deadlines.

Requirements

• Associate’s degree in a related scientific field, such as Biology, Veterinary Science, or Animal Science.
• At least three years of relevant experience with in vivo biological testing and processes in an academic or industry setting, such as medical device, pharmaceutical, or biotechnology.

Nice To Haves

• Bachelor’s degree in biology or a related scientific field.
• Experience with in vivo testing in the medical device industry.
• Hands-on experience with small laboratory animals in a research, academic, biomedical, pharmaceutical, biotechnology, or medical device environment, including animal handling, dosing or injections, blood collection, health assessments, husbandry, study support, and sample collection.
• Understanding of ISO 10993 testing requirements and hands-on experience with biocompatibility test methodologies.
• In-depth knowledge of GLP, GDP, and GMP in a medical device environment.
• RVT (Registered Veterinary Technician) and/or LAT (Laboratory Animal Technician) certification.
• Experience with ISO, USP, or ASTM biocompatibility evaluation requirements.
• Substantial knowledge of QSR, FDA, and ISO regulations.
• Knowledge of AALAS 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.
• Conduct in vivo studies using small animals, including mouse systemic toxicity, rabbit intracutaneous reactivity, and guinea pig maximization tests.
• Perform animal dosing and health assessments, prepare test samples, and follow study protocols and laboratory procedures.
• Collect and organize study data files and records.
• Maintain instruments and equipment according to manufacturer or in-house preventive maintenance and calibration/validation procedures.
• Keep the laboratory safe, clean, and orderly; perform functional checks on equipment such as CO2 incubators and refrigerators/freezers; facilitate storage, collection, and disposal of hazardous or biohazardous materials; and comply with health and safety regulations.
• Manage inventory of glassware, chemicals, reagents, and other supplies, including ordering, receiving, and storing materials.
• 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 and perform job functions in compliance with work instructions and SOPs.
• Initiate and support laboratory investigations and propose recommendations for manager review.
• Arrive on time, maintain regular attendance, and work a full eight-hour or longer period as required by testing volume and deadlines.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees’ and their families’ diverse individual needs

What This Job Offers

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