Applies expertise in chemistry to provide complex solutions. Key Responsibilities: • Qualify complex laboratory instrumentation and validate complex test methods while applying chemistry knowledge and concepts to perform environmental control testing, in-process solutions, and final product release testing for device qualifications • Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams • Provide strategy on root cause analysis for product/sample failures and Out-of-Specifications (OOS), non-conformances, and CAPA and guide other chemists perform investigations • Lead laboratory operations activities including maintaining work schedules to align with production • 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 in Chemistry, 8 years experience 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 • 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 • Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives • Extensive knowledge and understanding of Edwards policies and procedures relevant to chemistry • Extensive knowledge and understanding of chemical principles, theories and concepts • Extensive knowledge of laboratory equipment (e.g., gas Chromatography, high performance liquid chromatography, total organic carbon, Fourier transform infrared spectroscopy, atomic absorption) • Full 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 frequent inter-organizational and outside customer contacts • Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects