Senior Laboratory Technician, Biocompatibility Testing

Edwards Lifesciences•Irvine, CA

6d•$53,000 - $75,000•Onsite

About The Position

Edwards Lifesciences is seeking a Senior Laboratory Technician for their corporate Irvine, CA campus. This is an onsite position where the technician will conduct in vivo laboratory testing services within the Edwards Quality Lab (EQL). The role involves providing a comprehensive range of safety and biocompatibility testing for Edwards medical devices. The ideal candidate will be hands-on, thrive in a fast-paced environment, and play an active role in non-clinical testing to support manufacturing, new product development, and regulatory submissions to agencies like the FDA.

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).