Senior Laboratory Technician, Biocompatibility Testing

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 53,000 - 75,000; Full time

Job summary

Edwards Lifesciences Irvine, CA is seeking a Senior Laboratory Technician to conduct in vivo biocompatibility testing and support regulatory submissions for medical devices.

This onsite role requires hands-on work with small animals, data management, and adherence to GLP and ISO standards; you will train junior staff and lead improvement projects.

Applicants should have an Associate degree in a related field and at least three years of relevant experience in academic or industry settings.

Qualifications

• Associate's degree in biology, veterinary science, or a related field.
• Minimum 3 years of in vivo biological testing experience.
• Experience in academic or industrial settings (medical devices/pharma).

Responsibilities

• Perform and support in vivo testing and biocompatibility evaluation.
• Execute in vivo studies using small animals.
• Ensure animal dosing, health assessments, and sample handling.
• Maintain lab equipment and calibration/validation procedures.
• Lead small continuous improvement projects.
• Train and coach junior technicians on procedures.
• Ensure compliance with SOPs and regulatory guidelines.

Skills

In vivo testing

Biocompatibility testing

Lab safety

Education

Associate degree in biology or related field

Job description

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 recordsMaintains instruments and pieces of equipment in accordance with manufacturers or in-house preventative maintenance and calibration/validation proceduresMaintains 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 safetyManage the laboratory’s inventory for glassware, chemicals, reagents and other supplies by ordering, receiving and storingExecute equipment and method validation protocols with minimal supervisionLead small continuous improvement projectsMay train, coach, and guide lower-level technicians on new procedures, assess work techniques and provide feedback on proceduresReview, follow and perform job functions in compliance with established work instructions and adherence with SOPsInitiate and support laboratory investigations and propose recommendations for manager viewOn-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 fieldExperience with in-vivo testing within the medical device industryHands-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 methodologiesIn-depth knowledge of GLP (Good Laboratory Practices), GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) supporting a medical device environmentRVT (Registered Veterinary Technician) and /or LAT (Laboratory Animal Technician) certificationsExperience with ISO/USP/ASTM biocompatibility evaluation requirementsSubstantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulationsKnowledge of AALAS (American Association for Laboratory Animal Science) regulationsGood written and verbal communication, interpersonal, and relationship building skills and ability to read, comprehend, write and speak EnglishAligning 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.