Staff Technologist, Chemistry Laboratory

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Staff Technologist, Chemistry Laboratory position is a unique career opportunity that could be your next step towards an exciting future. Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. How you'll make an impact: Provide advanced technical and function-specific expertise to support routine and non-routine analytical chemistry testing in a regulated laboratory environment. Serve as a technical leader for laboratory test methods, instrumentation, investigations, method validation, and continuous improvement, supporting manufacturing, quality investigations, product development, and other cross-functional business needs. Apply in-depth knowledge and demonstrated proficiency across applicable chemistry testing, including raw materials, process solutions, purified water, sterilant solutions, chemical residuals, material identification, and other routine and non-routine analyses. Perform and provide technical oversight for analytical testing using established procedures and instrumentation such as titrators, UV-Visible spectrophotometers, FTIR, TOC analyzers, GC, HPLC, microplate readers, and other applicable laboratory systems. Identify technical risks, testing issues, and process improvement opportunities, and recommend scientifically sound solutions that maintain compliance with approved procedures, specifications, and regulatory requirements. Perform non-routine testing, technical evaluations, and special studies using approved procedures, protocols, work instructions, or documented study plans. Prepare technical summaries, analyses, trend reports, and laboratory study reports, and recommend improvements to templates, reporting tools, and documentation. Support execution of validation and qualification plans, protocols, and reports for analytical test methods, laboratory equipment, computerized systems, and other critical laboratory processes. Support the full analytical method lifecycle: development, feasibility assessment, validation, verification, transfer, implementation, maintenance, troubleshooting, and continuous improvement. Lead value and test method improvement projects that reduce testing time, labor, material usage, or operating cost while maintaining scientific validity and compliance with quality, regulatory, environmental, and safety requirements. Lead staff training and build laboratory technical capability by coaching and guiding technicians and less-experienced personnel on analytical methods, instrumentation, documentation practices, and troubleshooting. Assess analyst work techniques, provide professional feedback, and support qualification and certification activities for applicable methods. Coordinate daily testing activities, routine analyses, non-routine studies, and key deliverables with laboratory management, and support workload prioritization to meet manufacturing, investigation, and project timelines. Troubleshoot analytical methods, equipment, and software systems, determine when vendor or manufacturer support is required, and coordinate complex troubleshooting to restore equipment availability. Lead laboratory equipment procurement, installation, qualification, validation, calibration, and implementation by coordinating with laboratory personnel, Quality, Engineering, Information Technology, Metrology, Facilities, suppliers, and other stakeholders. Engage external vendors, instrument manufacturers, service providers, suppliers, and contract laboratories to support laboratory operations, technical investigations, equipment maintenance, and continuous improvement. Lead or provide technical support for investigations involving deviations, nonconformances, out-of-trend results, out-of-specification results, invalid tests, instrument failures, and data discrepancies. Support investigations documented through quality system records, including NCRs, CAPAs, OOTs, and OOS investigations, applying structured problem-solving tools to identify root cause, assess impact, and develop effective corrective and preventive actions. Develop, revise, review, and approve laboratory procedures, test methods, specifications, protocols, reports, forms, and work instructions, ensuring documentation is scientifically accurate, executable, controlled, and compliant with Good Manufacturing Practices and applicable standards. Maintain complete, accurate, contemporaneous, attributable, and traceable records in accordance with approved procedures and data integrity requirements. Support laboratory readiness for internal audits, external audits, regulatory inspections, and technical assessments. Perform all functions in compliance with company procedures, laboratory safety requirements, chemical hygiene practices, environmental requirements, and applicable regulatory standards. Perform other incidental duties, including laboratory housekeeping, chemical inventory support, cross-functional team participation, and maintenance of required training and certifications. What you need (Required): Associate's degree or equivalent technical degree/certificate, focused in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline, with 13 years of previous experience, including 3 years of relevant laboratory experience OR 15 years of previous work experience, including relevant laboratory experience What else we look for (Preferred): Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline with related experience above minimum requirements listed Experience in a medical device, pharmaceutical, biotechnology, or other regulated laboratory environment. Experience supporting manufacturing testing, laboratory investigations, method validation, method transfer, or product development. Advanced technical knowledge of analytical chemistry methods, instrumentation, calculations, associated data systems, and supporting laboratory systems. Demonstrated ability to independently perform, troubleshoot, and provide technical guidance for routine and non-routine analytical testing. Working knowledge of applicable FDA Quality System requirements, Good Manufacturing Practices, ISO 13485, United States Pharmacopeia, and other relevant compendial or regulatory standards. Knowledge of analytical method validation principles, including accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness, and system suitability, as applicable to the method. Knowledge of laboratory data integrity and good documentation practices. Experience with laboratory systems and software such as LIMS, chromatography data systems, instrument software, document management systems, and Microsoft Office applications; experience with systems such as ChemStation is preferred. Ability to interpret chromatograms, spectra, calibration data, instrument output, statistical results, and laboratory trends. Strong mathematical and analytical skills, including calculations involving concentrations, dilutions, percentages, averages, variability, and statistical evaluation. Ability to write clear, scientifically sound technical documents, including procedures, test methods, protocols, validation reports, technical reports, and investigation records. Ability to apply structured problem-solving and continuous improvement methodologies, such as Lean or Six Sigma, to laboratory processes. Ability to formulate and execute actionable technical plans from general objectives or instructions. Ability to manage routine assignments, non-routine technical work, and complex laboratory activities with limited supervision. Ability to work independently while providing technical guidance, coaching, and training to less-experienced laboratory personnel. Strong written and verbal communication, interpersonal, and relationship-building skills, including the ability to communicate technical information clearly to laboratory personnel, management, Quality, Engineering, Manufacturing, R&D, and other cross-functional stakeholders. Ability to provide feedback in a professional, direct, constructive, and tactful manner. Ability to collaborate effectively in an interdepartmental and multi-site team environment. Ability to represent the organization in interactions with external laboratories, contractors, suppliers, instrument manufacturers, and service vendors. Ability to read, comprehend, write, and speak English. Adhere to all company policies and requirements, including Environmental Health and Safety requirements. Implement appropriate controls to prevent injury, chemical exposure, environmental impact, and damage to laboratory equipment or facilities. 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 $81,000 - $114,000 (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.