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Staff Biologist (Quality Labs)

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

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.

Key Responsibilities: 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

Preferred Qualifications 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. SDL2017

Keywords: Edwards Lifesciences, Irvine , Staff Biologist (Quality Labs), Other , Irvine, California

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