
Senior Laboratory Technician, Biocompatibility Testing
Edwards Lifesciences
Summary
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.
Job description
How you will make an impact:
- 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)
What you’ll need (Required):
- 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).
What else we look for (Preferred):
- 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
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).
Benefits
- Competitive salaries
- Performance-based incentives
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Edwards Lifesciences (NYSE: EW) is the leading global structural heart innovation company, driven by a passion to improve patient lives. Founded in 1958 and headquartered in Irvine, California, the company specializes in developing breakthrough technologies for cardiovascular diseases. As a pioneer in the medical device industry, Edwards focuses on transcatheter heart valves, surgical heart valves, hemodynamic monitoring systems, and vascular solutions. The company's patient-focused culture inspires its 16,000+ employees worldwide to deliver life-changing innovations that address complex heart health challenges. Edwards serves patients in over 100 countries through its comprehensive portfolio of products including the SAPIEN transcatheter heart valve system, INSPIRIS surgical valves, and advanced monitoring technologies. With a commitment to research and development, the company invests 17-18% of its revenue back into R&D efforts, maintaining its position at the forefront of structural heart innovation. Edwards Lifesciences has impacted over one million patients globally through its transformative medical technologies.