Principal, Software Engineer

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%

Key Requirements/Minimum Qualifications:

• 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 Qualifications:

• 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)
• Must have C++, C# development experience.
• Must have a background with hardware/software interfaces within RTOS and Windows environments.
• Highly desired skills: MatLAB, LabView, FPGA, Firmware, and experience with camera interactions and interfaces.
• Familiar with object-oriented software design and large software architecture.
• 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
• Knowledge of networking and cybersecurity concepts are a plus.
• Experience with Microsoft Visual Studios or other integrated development environment (IDE) tools
• Prior experience creating and executing software testing at unit, sub-system, integration, and system levels.
• 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

How to Thrive at Alcon:

• Manage your own workload and schedule while hitting your set targets.
• Build positive working relationships to achieve positive goals and business objectives.
• Balance experiencing new environments and working autonomously in a remote sales environment.
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!

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Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay, with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and wellbeing, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.