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 Alcons 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 and MDR MDCGs ISO 13485 ISO 14971 IEC 62304 IEC 60601 and Alcon Quality System. Responsible for local implementation of these processes and influencer of global practices.

Plans and owns or drives execution of quality and value-add design control and risk management deliverables in collaboration with project core teams and functional stakeholders in support of project milestones and objectives.

Design Control deliverables ownership may include but not be limited to Design Plans Design Inputs Traceability Matrices Design Verification and Validation Plans and Summary Reports Design Review Reports.

Leads Design Phase Reviews. Collaborates with R&D Lead and rest of Core team to assemble design review material that tells the story of the design makes relevant conclusions provides evidence that the development was executed according to the design plan and facilitates the independent review of the design.

Leads systematic approach to requirement management including traceability of design inputs to design outputs design verification and validation and traceability to risk management.

Leads systematic approach to risk management (including usability) from planning to identifying and assessing risks by championing use of appropriate tools (e.g. Hazards Analysis FTA FMEA Task Analysis) driving identification and implementation risk controls benefit-risk analyses consideration of State of the Art (SotA) and disclosure of residual risks. Works with the technical and medical experts to drive the process. Responsible for authoring and updating Risk Management Reports.

Coaches teams on effective and efficient application of the design control and risk management processes including usability product security and software development establishes best practices and disseminates them across the organization.

Preferred Qualifications/Skills/Experience:

Medical device product development (electrical mechanical optical software)

Design control for medical devices development (21 CFR 820.30 ISO 13485 MDD/MDR)

Risk Management for medical devices (ISO 14971)

SW development for medical devices (IEC 62304) including SiMD and SaMD

Medical electrical equipment basic safety & essential performance IEC 60601 series

Usability Engineering for medical devices (IEC 62366-1)

Product Security for medical devices

Licenses and Certifications (Preferred):

Medical Device Risk Management / ISO 14971

Medical Device Design Control (21 CFR 820.30 ISO 13485 MDD/MDR)

Agile Development / Scrum Master

Six Sigma

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