Job description

Applies expertise in chemistry to provide complex solutions.

Key Responsibilities:

• Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams while drive the science and changes in the science of chemistry (e.g., (EQL) EW Quality Laboratory study directors, (L/E) leachable and extractable)
• Drive compliance, policy and procedures chemical activities
• Key technical contact in providing strategy on root cause analysis for process product failures, non-conformances, and CAPA
• Qualify all laboratory instrumentation including complex equipment (e.g., mass spectrometry) and validate complex test methods while applying chemistry knowledge and concepts to perform product qualifications
• Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
• Provide solutions and lead in the validation of new laboratory equipment
• Lead complex process improvement projects (e.g., BEST, Lean) and work with team to provide solutions
• Perform testing as needed

Education and Experience:
Bachelor's Degree in Chemistry, 10 years of previous related experience Required or
Master's Degree or equivalent in Chemistry, 8 years of previous related experience Required or
Ph.D. or equivalent in Chemistry, 6 years of previous related experience Required

Additional Skills:

• Proven successful project management skills
• Proven expertise in MS Office; Analytical Equipment System (e.g., ChemStation, Empower)
• Excellent facilitation and presentation skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Recognized as an expert in own area with specialized depth within the organization
• Expert knowledge and understanding of Edwards policies and procedures relevant to chemistry
• Expert knowledge and understanding of chemical principles, theories and concepts
• Expert knowledge of laboratory equipment (e.g., gas Chromatography, high performance liquid chromatography, total organic carbon, Fourier transform infrared spectroscopy, atomic absorption)
• Extensive knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
• Ability to manage confidential information with discretion
• Strong leadership skills and ability to influence change
• 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
• Ability to work in a team environment, including representing organization as key technical contact on contracts and projects
• Ability to interact with senior external representatives (e.g., regulatory agencies, FDA, DEKRA, TUV, MHLW) on significant technical 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

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 13,000 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

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