Alcon is looking to develop medical digital platform solutions and needs a Principal Software Systems Engineer to ensure adherence to system requirements, regulatory standards, and quality metrics within the medical device industry.
Requirements
- 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.
Responsibilities
- 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.
Other
- Located in either Fort Worth, TX or Lake Forest, CA
- Bachelor’s degree in computer science, biomedical engineering, or related field with 8+ years of experience in systems engineering and software engineering.
- The ability to fluently read, write, understand, and communicate in English
- Travel Requirements: 0-5%
- Sponsorship available: No
