Principal, Software Engineer

Alcon•Lake Forest, CA

11d•$128,350 - $166,100•Onsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? The Principal Software Engineer is responsible for maintaining, enhancing, and supporting software for on-market medical device products, ensuring continued product reliability, compliance, cybersecurity, and lifecycle sustainability. This role focuses on evaluating and implementing software changes driven by end-of-life (EOL) components, supplier hardware updates, cybersecurity requirements, and field-reported issues. The position is responsible for investigating software anomalies, assessing impacts to existing systems, and defining practical, compliant solutions that maintain product performance and customer satisfaction. The role serves as a key liaison between engineering, customer-facing teams, product security, verification and validation, and global software development organizations. It ensures that software changes are properly assessed, documented, tested, and released in accordance with quality system requirements and medical device regulations. The Principal Software Engineer collaborates closely with onshore and offshore development and V&V teams throughout the software development lifecycle, providing technical inputs for testing, validating software modifications, supporting troubleshooting activities, and maintaining software configuration management. The role enables successful delivery of software updates while ensuring adherence to company policies, regulatory requirements, and product quality standards. This is an onsite position located at our main campus in Lake Forest, California. In this role, a typical day will include: Primary function is to code and/or software updates for on-market medical device systems. Collaborate closely with the software development teams, Technical Support, Field Service, Manufacturing, Clinical and other operation organizations to support necessary software changes initiated by reported anomalies, changes in use cases, material or hardware changes that impact software, cybersecurity, regulatory updates, and other. Troubleshoot, and define solutions to meet expectations, and incorporate changes according to defined processes and procedures, in line with industry standards and regulations. Maintain configuration management and change control according to the associated product Configuration Management Plan and Change Control procedures. Document and execute change-related unit and integration tests. Provide inputs for scope, impact, and effective test methodologies for testing. Assure compliance to software release procedures for post-Market changes to on-market products. Travel required, est. 10-20%

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
Must have C++, C# development experience.
Must have a background with hardware/software interfaces within RTOS and Windows environments.
Ability to work cross-functionally with a variety of stakeholders.
Ability to work independently, proactively identify issues, recommend, and implement solutions, and deliver quality results on schedule while managing multiple tasks and internal customers.
Solid understanding of Window operating environments (Win11, Win10, etc.)
Experience with one or more software configuration management systems and related tools, such as: AWS DevOps, Jira, Git, ADO, GitHub, TFS
Prior experience creating and executing software testing at unit, sub-system, integration, and system levels.

Nice To Haves

Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
Systems Engineering or Risk Management for Medical Device (ISO 14971)
Medical Device Software – Software Life Cycle Processes (IEC 62304)
Regulations and Guidelines associated with software development for medical device
Microsoft Office suite (i.e., Word, Excel, Visio)
MatLAB, LabView, FPGA, Firmware, and experience with camera interactions and interfaces.
Familiar with object-oriented software design and large software architecture.
Knowledge of networking and cybersecurity concepts are a plus.
Experience with Microsoft Visual Studios or other integrated development environment (IDE) tools
Familiar with FDA/ISO regulations for software development and/or EUMDR, prefer including IEC 62304
Understanding of Software Development Lifecycle Management (SDLC) – (Agile/Scrum, iterative)
Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote, and asynchronous environment.
Medical device experience is preferred

Responsibilities

Code and/or software updates for on-market medical device systems.
Collaborate closely with the software development teams, Technical Support, Field Service, Manufacturing, Clinical and other operation organizations to support necessary software changes initiated by reported anomalies, changes in use cases, material or hardware changes that impact software, cybersecurity, regulatory updates, and other.
Troubleshoot, and define solutions to meet expectations, and incorporate changes according to defined processes and procedures, in line with industry standards and regulations.
Maintain configuration management and change control according to the associated product Configuration Management Plan and Change Control procedures.
Document and execute change-related unit and integration tests.
Provide inputs for scope, impact, and effective test methodologies for testing.
Assure compliance to software release procedures for post-Market changes to on-market products.