Senior Laboratory Technician, Biocompatibility Testing

Edwards Lifesciences; Irvine (CA); Sur place; USD 53 000 - 75 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Incentives

Benefits package

Résumé du poste

Edwards Lifesciences is seeking a Senior Laboratory Technician to conduct in vivo testing and support biocompatibility evaluations for medical devices at the Irvine, CA campus. The role emphasizes hands-on animal studies, strict adherence to GLP/GMP, and collaboration with manufacturing and development teams.

The successful candidate will have an Associate’s degree in a related field and at least three years of in vivo testing experience, with preferred Bachelor’s degree and experience in the

Qualifications

• Associate’s degree in a related scientific field (Biology, Veterinary Science, Animal Science, or similar).
• At least three (3) years of experience with in vivo biological testing in academic or industry settings (medical device/pharma/biotech).
• Hands-on experience with small laboratory animals and adherence to GLP/GMP/ISO guidelines.

Responsabilités

• Perform and support in vivo testing and operations to evaluate biocompatibility and biological safety.
• Conduct in vivo studies with small animals (mouse, rabbit, guinea pig) and manage dosing and health assessments.
• Maintain equipment, calibrations, and safe handling of biohazardous materials in compliance with SOPs.
• Organize study data files and records; manage inventory of glassware, reagents, and supplies.
• Lead small continuous improvement projects and potentially train junior technicians.

Connaissances

In vivo testing

Animal handling

Lab safety

Data collection

GLP/GMP knowledge

Formation

Associate’s degree in biology/veterinary/animal science

Bachelor’s degree (preferred) in biology or related field

Description du poste

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.

This is an onsite position at our corporate Irvine, CA campus. Work schedule is Monday - Friday, with overtime or occasional weekend hours as required based on testing volume and deadlines.

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.

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

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 (CA), the base pay range for this position is $53,000 to $75,000 (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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.