Principal Chemist

Edwards Lifesciences seeks a Principal Chemist to lead analytical chemistry and mass spectrometry-based structural elucidation of extractables and leachables for cardiovascular medical devices. The role involves developing and validating analytical methods, providing technical oversight for complex investigations, and mentoring laboratory staff.

Responsibilities

• Develop, validate, and perform testing on extractables and leachables using HPLC-MS, GC-MS, and ICP-MS
• Conduct mass spectrometry structural elucidation and routine analysis of medical device samples
• Lead technical direction for complex laboratory methods and provide oversight for testing and qualification strategies
• Direct root cause analysis, deviation investigations, and corrective/preventive actions for product failures and out-of-specification results
• Mentor lower-level employees and guide technical decision-making across assigned methods and programs

Requirements

• Bachelor's degree in Chemistry with 8 years of mass spectrometry and unknowns analysis experience, OR Master's with 6 years relevant experience, OR Ph.D. with 4 years experience
• Expertise in LC-MS, GC-MS, and ICP-MS techniques for structural elucidation
• Strong knowledge of laboratory equipment and analytical instrumentation platforms
• Familiarity with ISO, GLP, GMP standards and medical device manufacturing practices
• On-site presence required; up to 25% travel