Biologist II

Edwards Lifesciences Corp Irvine , CA 92606

Posted 2 months ago

This position will serve as Study Director (e.g., Interpret data and define qualification strategies for new or modified devices and/or processes) and lead in vitro and in vivo biocompatibility studies for new and in-process products including in vitro testing (e.g., cytotoxicity, hemolysis, heparin testing) and in vivo testing (e.g., systemic toxicity, intracutaneous reactivity, implantation testing, sensitization testing). Collaborate with project teams to assist in establishing test recommendations and testing in biocompatibility guidelines by the International Organization for Standardization (ISO) 10993 OR Conduct moderately complex genotoxicity assays (e.g., Ames - Plate Incorporation Test, Chromosomal Aberration, Micronucleus test) utilizing advanced pipetting techniques.

Other Essential Duties:

  • Lead smaller process improvement projects (e.g., BEST, Lean) and propose recommendations for manager approval.

  • Develop non-routine protocols, reports, and methods in collaboration with inter-departmental teams.

  • Investigate and perform lab and manufacturing corrective and preventative actions (CAPA).

  • May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures.

  • Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ).

  • Other incidental duties assigned by Leadership.



Education / Requirements /

  • Bachelor's degree in a related field, and a minimum of 4 years of relevant experience in biocompatibility testing, including in vitro and in vivo; OR Master's degree in related field and 2 years of relevant experience in biocompatibility testing, including in vitro and in vivo.

  • Excellent written and verbal communication skills and interpersonal relationship skills.

  • Demonstrated problem-solving and critical thinking skills.

  • Moderate knowledge and understanding of Edwards policies and procedures relevant to biology.

  • Moderate knowledge and understanding of biology principles, theories and concepts.

  • Excellent written and verbal communications skills.

  • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

  • Advanced problem-solving skills and strict attention to detail.

  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.

  • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.

  • Ability to interact professionally with all organizational levels.

  • Ability to manage competing priorities in a fast-paced environment.

  • Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness.

  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Substation Electrical EIT II

Hdr, Inc.

Posted Yesterday

VIEW JOBS 5/23/2019 12:00:00 AM 2019-08-21T00:00 About Us At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We create an unshakable foundation for progress because our multidisciplinary teams also include scientists, economists, builders, analysts and artists. That's why we believe diversity is our greatest strength. HDR is proud to be an equal opportunity workplace and an affirmative action employer. Watch our 'About Us' video We believe that the way we work can add meaning and value to the world. That ideas inspire positive change. That coloring outside the lines can illuminate fresh perspectives. And that small details yield important realizations. Above all, we believe that collaboration is the best way forward. Primary Responsibilities HDR Engineering is currently seeking a Substation Electrical EIT II to join our growing and nationally-ranked team of Power Delivery professionals in our Irvine-based Substation team. This role is an integral part of a team that executes technical design on substation engineering projects ranging in scale from simple device replacements to large greenfield design projects. This is an excellent growth opportunity for a self-directed individual who is eager to learn and take on new challenges. The primary duties of a Substation Electrical EIT include preparation of engineering drawings, calculations, analyses, reports and designs for electrical substations (Low, Medium and High Voltage) and substation systems under the direction and supervision of s Hdr, Inc. Irvine CA

Biologist II

Edwards Lifesciences Corp