Principal Software Systems 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 Systems Engineer will be located in either Fort Worth, TX at Alcon's US headquarters or in Lake Forest, CA at Alcon's R&D facility and will play a critical role in the development of medical digital platform solutions at Alcon, working closely with pod-structured development teams, cross-functional teams to ensure adherence to system requirements, regulatory standards, and quality metrics. This position requires deep expertise in software development life cycles, systems engineering, stakeholder management, and compliance within the medical device industry. This role is part of Alcon's Information Technology function, a team that delivers cutting-edge technology solutions to Alcon associates and customers to help our people and the world see brilliantly.
 

In this role, a typical day will include:

• Collaborate closely with the product team, UI/UX team, scrum master, and program manager to take accountability and responsibility for system requirements.

• Act as the primary liaison between the development team and other departments including QA, Product, Service, Regulatory, IT, and R&D for product development initiatives.

• Demonstrate a deep understanding of software development life cycles to effectively collaborate with the V&V team, deployment team, and service team.

• Write system requirements and specifications (SYRS) and software requirements and specifications (SRS) for complex medical devices or software-as-a-medical device.

• Accountable for the Design History File (DHF) for the digital surgical platform, ensuring comprehensive documentation and compliance with regulatory standards.

• Work closely with all team members, providing subject matter expertise to diagnose defects and formulate solutions during testing cycles.

• Implement risk management processes, including hazard analysis and mitigation strategies, in accordance with regulatory requirements.

• Ensure compliance with industry standards and maintain high-quality standards throughout the software development processes.

• Stay informed about industrial trends and maintain domain expertise in medical software development.

Experience:

• Bachelor’s degree in computer science, biomedical engineering, or related field with 8+ years of experience in systems engineering and software engineering. Deep expertise and experience with writing system requirements and specifications (SYRS) and software requirements and specifications (SRS) for complex medical devices or software-as-a-medical device

• Proficiency in Agile software development methodologies and practices.

• Strong system engineering expertise with the ability to design and architect complex systems to meet the needs of medical software applications.

• In-depth understanding of regulatory requirements and standards for medical software industry, such as IEC 62304, ISO 13485, and FDA regulations.

• Ability to lead cross-functional teams and drive consensus on complex technical decisions.

What You'll Bring to Alcon:

• 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

How You Can Thrive at Alcon:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

• Travel Requirements: 0-5%

• Relocation assistance: Yes

• Sponsorship available: No

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Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.  The first layer of our rewards program is compensation.  We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.  Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.  To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

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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.