Sr. Associate I, Research & Development Process & Product Design (T)

Summary of Position:

Alcon is seeking a Sr. Associate Engineer to join our Research and Development team. This role will focus on applying Design Control and Risk Management principles to software development, including Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and non-clinical software applications that support Alcon's ecosystem of instruments and software solutions.

Key Responsibilities:

• Responsible for developing Design History Files (DHFs) and Risk Management Files (RMFs) that support effective and efficient global registrations and launches of quality products, e.g., minimize regulatory agencies questions during submission, minimize gaps that may result in audit findings, minimize CAPAs caused by lack of design control discipline.
• Acts as Subject Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD a...