This 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 assays  
• Prepare test samples (products/materials/components) for routine and qualification testing. Perform the cultivation and maintenance of cell/bacterial cultures as required for any in vitro testing
• 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)

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 field
• Experience with in-vitro testing within the medical device industry
• 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
• 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

Aligning 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.