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.

This is an opportunity to join a state-of-the-art medical device chemical characterization laboratory and center of excellence for analytical chemistry and unknowns analysis. The Principal Chemist will specialize in mass spectrometry-based structural elucidation of extractables and leachables and the development, validation, optimization, and troubleshooting of analytical methods using liquid chromatography mass spectrometer (LC-MS and gas chromatography mass spectrometer (GC-MS), with inductively coupled mass spectrometer (ICP-MS) and related technologies supporting broader chemical characterization and complex investigations.

How  you’ll make an impact:

• Support the test method development, validation, and testing on Extractables and Leachables using high performance liquid chromatography mass spectrometer (HPLC-MS), GC-MS, and ICP-MS.
• Perform mass spec structural elucidation of extractables and leachables.
• Support routine analysis of leachables and extractables and EO/ECH residual on medical device.
• Assist in test method development and validation for a variety of cleaning validations using GC-MS, GC-MS/HS, HPLC-MS, HPLC-DAD, ICP-MS, TOC, FT-IR, UV, etc.
• Own technical direction for complex laboratory methods, instrumentation platforms, and investigation approaches across multiple workstreams. Provide technical oversight for complex testing, data review, and qualification strategies for new or modified devices and/or processes.
• Provide technical authority for root cause analysis of product/sample failures and Out-of-Specifications (OOS), incidents, deviations and their significance, non-conformances, and CAPA; review technical conclusions, resolve escalated issues, and determine appropriate corrective and preventive actions.
• Establish technical expectations and execute development, modification, verification, validation, transfer, and lifecycle management of methods, lab-specific protocols, and reports in collaboration with intra- and inter-departmental teams.
• Define technical strategy for equipment qualifications and software validation activities for complex analytical systems and ensure alignment to laboratory and quality requirements.
• Establish expectations and perform interpretation of data and analysis of results, including statements of conformity or opinions and interpretations, trend analysis, and qualification strategies for new or modified devices and/or processes.
• Lead standardization of laboratory practices, technical decision-making, and review expectations across assigned methods, platforms, or programs.
• Lead complex process improvement projects (e.g., BEST, 6S, Lean), update procedures/forms, support safety and quality initiatives, and implement sustainable changes with management approval.
• Mentor and technically guide lower-level or new employees; report, review and authorize results; assess work techniques and provide feedback on procedures, methods, and technical rigor.
  

What you’ll need (Required):

• Bachelor's Degree in Chemistry or equivalent with 8 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation; OR
• Master's Degree in Chemistry or equivalent with 6 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation; OR
• Ph.D. or equivalent in Chemistry or equivalent with 4 years of previous related experience with unknowns analysis using mass spectrometry techniques and/or structural elucidation.
• On‑site presence required to collaborate cross‑functionally and support manufacturing operations.
• Travel requirement up to 25%.

What else we look for (Preferred):

• 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).
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
• Proven successful project management skills.
• Proven expertise in MS Office; Analytical Equipment System (e.g., ChemStation, MassHunter).
• Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
  
  

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.