Laboratory Technician, Biocompatibility Testing

Edwards Lifesciences•Irvine, CA

4d•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 Laboratory Technician position is a unique career opportunity that could be your next step towards an exciting future. This role is onsite at our Irvine Corporate Campus. Work shift is Monday - Friday with occasional weekend rotation amongst the team. Overtime required during peak volume periods or critical deadlines. The Lab Technician will conduct in vitro and 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. The Laboratory Technician will perform in vitro and in vivo testing services in support of non-clinical studies and in-process assessments conducted by the Edwards Quality Laboratory.

Requirements

Associate's degree in related scientific field (Biology, Veterinary Science, Animal Science, or similar)
At least one (1) year of relative experience with in vitro and in vivo biological testing and processes within an academic or industry setting (i.e. medical device/pharmaceutical/biotech).
Able to read, comprehend, write and speak English

Nice To Haves

Experience with in-vivo and in vitro laboratory test methods
Experience as a veterinary technician in biomedical research or private practice
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.
Experience in a GLP / GDP lab environment supporting Medical Devices a big plus (not required)
Basic knowledge of AALAS (American Association for Laboratory Animal Science), USDA, DEA regulations
RVT (Registered Veterinary Technician) and /or LAT (Laboratory Animal Technician) certifications
Demonstrates professional communication, interpersonal, and relationship building skills
Intermediate knowledge of MS Office Suite (Outlook, Excel, Word)
Thrives in a collaborative team environment with close supervision

Responsibilities

Perform a variety of routine laboratory tests and assist in laboratory tasks as required under close supervision of Laboratory Supervisor and Study Directors
Perform and/or assist in biology laboratory testing and processes in in vitro area. The test includes but is not limited to cytotoxicity, hemolysis, partial thromboplastin time, platelet leukocyte counts, completement activation, and genotoxicity assay.
Perform in vivo biological assays using small animals, including administration, health monitoring, and test sample collection per ISO 10993. The in vivo tests include mouse systemic toxicity, rabbit intracutaneous reactivity, and guinea pig maximization tests.
Lab functions include collecting, analyzing, and processing laboratory samples.
Prepare chemicals, reagents and solutions.
Calibrate and operate standard laboratory equipment that is maintained in electronic system.
Record results, organize data, and perform basic computations.
Initiate and support laboratory investigations.
Assist in validation activities for equipment and test methods under close supervision
Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
Other incidental duties as assigned