Senior Toxicologist

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Senior Toxicologist will manage development and implementation of biological safety test strategies and conduct toxicological risk assessments to support biological evaluations of Edwards Lifesciences medical devices.  

This position is remote and open to US (United States) based candidates. Occasional travel may be required.

How you will make an impact:
• Assess test data and write and approve Toxicological Risk Assessments and Biocompatibility Safety reports
• Review and interpret test results for biocompatibility studies. Propose recommendations and feedback on questionable data and test failures to leadership
• Lead in the development of test recommendations and testing in compliance with biocompatibility guidelines by the International Organization for Standardization (ISO) 10993. Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams
• Lead complex process improvement projects (e.g., BEST, Lean) and work with team to provide solutions
• Provide guidance and interpretation of regulatory guidelines related to medical device submissions for all Edwards business units

• Other critical or incidental activities as assigned 

What you will need (required):

• Bachelors Degree in Biological Sciences (e.g., Biology, Chemistry, Toxicology), plus minimum of four (4) years' experience in relative biocompatibility testing strategies and standards required OR

• Master's Degree in Biological Sciences, plus minimum of two (2) years' relative experience required. 

What else we look for (preferred):

• Experienced with critical evaluations of in vivo and / or in vitro toxicological studies

• Experience in conducting risk-based assessments of chemicals under ISO 10993-1 and 17

• Relative knowledge in the review, evaluation, interpretation, and implementation of internal and external standards guidance  (e.g., ISO, GLP/GMP/QSIT)

• Advanced knowledge and understanding of toxicology and biological safety principles, theories and concepts

• Working knowledge of relative laboratory equipment (e.g., microscope, spectrophotometer, flow cytometer, analytical balance, centrifuge)
• Moderate knowledge of Good Manufacturing (cGMP) and Good Documentation Practices (GDP) in the Medical Device or Biotechnology industry highly preferred. 

• Advanced utilization of MS Office Suite (Outlook, Word, Excel, Power Point, MS Project) 

• Proven end to end project management experience preferred. 

• Exhibits professional communication (written / verbal) and relationship management skills in ability to drive achievement of business objectives

• Ability to manage competing priorities in a dynamic environment with strict attention to detail

• Thrives in a cross functional, team-oriented environment with ability to build relationships across all organization and leadership levels

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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 

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.

The base pay range for this position is $101,000 to $142,000(highly experienced).   

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).   

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

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with h