Alcon · 2 days ago
Principal Software Engineer, Design Control New Product Development (NPD)
Lake Forest, CA
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $175K/yr
5+ years expAlcon is a global leader in eye care, dedicated to helping people see brilliantly. The Principal Software Engineer will apply Design Control and Risk Management principles to software development for medical devices, ensuring quality product registrations and launches while collaborating with project teams.
Health CareManufacturingMedical Device
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
Qualification
Required
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
Preferred
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
Benefits
Health
Life
Retirement
Paid time off
Relocation assistance
Sponsorship available
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
H1B Sponsorship
Alcon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (35)
2023 (12)
2022 (15)
2021 (45)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
2026-01-21
Company data provided by crunchbase