Principal Software Engineer, Design Control New Product Development (NPD)

Alcon•Lake Forest, CA

1d•$105,000 - $175,000

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Principal Engineer within the Research and Development team in Lake Forest, CA, you will be trusted to apply 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. In this role, a typical day will include: Responsibility 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. Acting 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. Planning and owning, or driving 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. Designing Control deliverables ownership which may include, but not be limited to, Design Plans, Design Inputs, Traceability Matrices, Design Verification and Validation Plans and Summary Reports, Design Review Reports. Leading Design Phase Reviews. Collaborating 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. Leading a systematic approach to requirement management, including traceability of design inputs to design outputs, design verification and validation and traceability to risk management. Leading a 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. Working with the technical and medical experts to drive the process. Responsible for authoring and updating Risk Management Reports. Coaching 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.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience

Nice To Haves

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)
Software 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
Medical Device Risk Management / ISO 14971
Medical Device Design Control (21 CFR 820.30, ISO 13485, MDD/MDR)
Agile Development / Scrum Master
Six Sigma

Responsibilities

Responsibility 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.
Acting 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.
Planning and owning, or driving 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.
Designing Control deliverables ownership which may include, but not be limited to, Design Plans, Design Inputs, Traceability Matrices, Design Verification and Validation Plans and Summary Reports, Design Review Reports.
Leading Design Phase Reviews.
Collaborating 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.
Leading a systematic approach to requirement management, including traceability of design inputs to design outputs, design verification and validation and traceability to risk management.
Leading a 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. Working with the technical and medical experts to drive the process. Responsible for authoring and updating Risk Management Reports.
Coaching 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.