Edwards Lifesciences Staff Biologist (Quality Labs) in Irvine, California
The Quality Labs provide a comprehensive range of testing and consulting services for safety and biocompatibility evaluation of medical devices. The Staff Biologist will participate in the development and implementation of biological safety test strategies in compliance with ISO 10993, for submissions to FDA and other regulatory agencies. We are looking for an experienced scientist who enjoys being hands on, working in a fast-paced environment, and who can effectively lead biocompatibility safety evaluation strategy for a variety of medical devices.
Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams.
Qualify complex laboratory instrumentation and validate test methods.
Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures.
Lead complex process improvement projects (e.g., BEST, Lean) and work with team to provide solutions.
Education and Minimum Requirements
Bachelor’s degree in Biology or related field with 8 years of relevant industry experience in biocompatibility or biological related field, OR
Master’s degree or equivalent experience in a related field, and 6 years of relevant industry experience, OR
Ph.D. or equivalent experience in a related field, and 4 years of relevant industry experience
- Experience in materials biocompatibility and risk assessments for medical devices preferred
Additional Talents and General Expectations:
Extensive knowledge and understanding of Edwards’ policies and procedures relevant to Biology
Extensive knowledge of laboratory equipment (e.g., flow cytometer, coagulation analyzer, multi-plate reader, microscope, spectrophotometer, analytical balance, centrifuge)
Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP) required
Expert understanding of FDA and EU regulatory requirements for medical device industry
Ability and desire to work effectively in a multidisciplinary team environment
Thorough working knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP)
Excellent written and oral communication skills, including strong formal presentation and analytical skills
Excellent problem-solving, organizational, analytical and critical thinking skills
High energy, and resourceful person who is capable of quickly taking control of his responsibilities, building capable strategies and establishing self as a credible strategic partner
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Strong leadership skills and ability to influence change
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.