Develop related protocols by applying microbiological knowledge and concepts.
Key Responsibilities:
- Conduct studies to establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols
- Identify basic testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards
- Develop protocols, reports, and methods in collaboration with inter-departmental teams
- Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing
- Participate in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval
- Collect samples for studies
- Create and develop validation plans for laboratory equipment and methods
- Investigate and perform lab corrective and preventative actions (CAPA) testing
- Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes
- May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
- Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree in In Microbiology
Additional Skills:
- Proven expertise in MS Office Suite
- Good written and verbal communication skills and interpersonal relationship skills
- Demonstrated problem-solving and critical thinking skills
- Good knowledge and understanding of Edwards policies and procedures relevant to microbiology
- Good knowledge and understanding of microbiology principles, theories and concepts
- Good understanding of at least one of the following areas: sterilization process, final release testing, and environmental controls
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Strict attention to detail
- 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 sections of projects and/or lines of work and reviewed for accuracy and soundness
- 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, the base pay range for this position is $55,000 to $78,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
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 18,500 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.
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 healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice