Principal Microbiologist Jobs

Edwards’ Microbiology Quality Lab provides guidance, strategy, design and conducts studies for all related microbiological testing across a spectrum of our cardiovascular products.
This is an exciting role for an experienced Principal Microbiologist in leading and supporting complex compliance and risk assessment activities related to new product development and manufacturing sustaining activities as it relates to contamination control and sterilization (Radiation and Ethylene Oxide).
Position is onsite (M-F), based out of the Edwards Global Corporate Campus in Irvine, CA. Comprehensive relocation benefits available for eligible US based candidates. Not able to accommodate candidates requiring 100% remote or unable to relocate.
Key Responsibilities:
Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams while driving the science and changes in the science of microbiology (e.g., (EQL) EW Quality Laboratory study directors, Sterilization Assurance)
Qualify complex laboratory instrumentation and validate complex test methods while applying microbial knowledge and concepts to perform environmental control testing, in-process solutions, and final product release testing for device qualifications
Provide strategy and guide other microbiologists on root cause analysis for product/sample failures, Out-of-Specifications (OOS), non-conformances investigations
Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
Lead laboratory manufacturing sustaining operations activities including maintaining work schedules to align with production
Provide solutions and lead in the validation of new laboratory equipment
Lead complex critical system improvement projects (e.g. BEST, Lean) and work with team to provide solutions
May be a on a working group/committee in support of a compliance guide
Education and Experience Requirements:
Bachelors Degree in Microbiology, or related scientific field, plus a minimum of 8 years relative experience required.
Masters or PhD in Microbiology or relative science field may offset some required experience
Experience in medical device sterilization experience with concentration in Radiation and Ethylene Oxide required
Preferred Qualifications:
Proven technical skills with multiple sterilization processes
Sterilization experience supporting class III medical devices
Additional Talents and General Expectations:
Advanced knowledge of the compliance guides for environmental controls or a sterilization process (proficiency in ISO 11135 and ISO 11137)
Extensive knowledge and understanding of Microbiology principles, theories and concepts
Extensive knowledge of laboratory equipment
Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
Track record in successful project management, meeting facilitation and presentations.
Demonstrates strict attention to detail, analytical and critical thinking abilities
Professional level proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
Ability to manage confidential information with discretion
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Ability to manage competing priorities in a fast-paced environment
Thrives in a collaborative team environment, with strong leadership, relationship management and ability to influence change.
Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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 $106,000 to $151,000 (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