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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. As the Senior Biologist, you represent the Study director to conduct pre-clinical biocompatibility GLP studies

How you will make an impact:

• Serve as GLP 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, genotoxicity and hemocompatibility endpoints) and in vivo testing (e.g., systemic toxicity, intracutaneous reactivity, implantation and sensitization endpoints).

• Collaborate with project teams to establish test recommendations and testing in compliance with biocompatibility guidelines by the International Organization for Standardization (ISO) 10993.

• Supervise the technical conduct of GLP studies and Coordinate testing to be performed in-house and at Contract Research Organizations (CROs), Review and interpret test results for biocompatibility studies

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

• Provide technical support to all Edwards Lifesciences R&D teams for the qualification of new or modified devices and processes

• Support continuous improvement initiatives by exploring alternate biocompatibility methods and developing new processes focusing on quality and regulatory compliance.

• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's degree in Biology or related field, 4 years' experience OR

• Master's Degree or equivalent in biology or related field, 2 years’ experience OR

• PhD Degree in biology or related field.

What else we look for (Preferred):

• Experience or full knowledge in biocompatibility testing including in-vitro and in-vivo in compliance with ISO 10993 standards

• Excellent written and verbal communication skills and interpersonal relationship skills

• Demonstrated problem-solving and critical thinking skills

• Full knowledge and understanding of Edwards policies and procedures relevant to biology

• Full knowledge and understanding of biocompatibility principles, theories and concepts

• Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations

• Full knowledge with ISO/USP/ASTM biocompatibility evaluation requirements

• Ability to write technical documents and present recommendations to internal and external stakeholders

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

• Keep up to date with industry trends and standards for biocompatibility evaluations

• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to laboratory environment

• Strict attention to detail

• Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) supporting a medical device environment

• Ability to interact professionally with all organizational levels

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

• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

• 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.

For California (CA), the base pay range for this position is $90,000 to $127,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.