Senior/Staff/Principal Software Qa Engineer

Open Position – Senior/Staff/Principal Software QA Engineer

Horizon Surgical Systems Inc.

Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. Horizon Surgical Systems Inc. aims to expand access to care, provide superior capabilities to the human surgeon, and enhance patient outcomes. Microsurgery in general and Ophthalmology are subfields of surgery for which the surgical outcomes can be significantly improved by robotic systems to allow superior dexterity, precision, accuracy, and visualization beyond the human surgeon's own capabilities.

We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology. The core values of Horizon Surgical Systems Inc. are:

• Commitment to Excellence: We aim to deliver superior patient outcomes and surgeon experiences
• Passion for Creativity and Innovation: We are driven by new ideas and aim to push the boundaries of what's possible
• Teamwork and Camaraderie: We achieve our best when we collaborate and work together
• Welcoming of Critical Opinion: We are enriched by constructive criticism and support the best ideas
• Personal Accountability: We honor our commitments and take responsibility for our actions

Horizon Surgical Systems Inc. offers:

• An opportunity to build autonomous surgical robotic systems driven by image guidance and AI technology for the future of affordable, high-quality healthcare.
• The opportunity to work alongside clinicians, engineers, and global leaders in cutting-edge AI, imaging, and robotics technology.
• Competitive compensation and an excellent company-paid benefits package.

In your role as an engineer at Horizon Surgical Systems, you will design components and systems (hardware and software) as part of a complete product subjected to FDA regulations. Your design will be subject to safety and efficacy requirements

The level of title will be determined case by case, based on the candidate's qualifications and years of experience: senior engineer, staff engineer, principal engineer or higher.

Required Qualifications and Abilities:

• Educational Background:
• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Robotics, or a related field.
• Technical Skills:
• Programming Languages: Proficiency in languages like C/C++, Python, Java, or other relevant languages.
• Operating Systems: Proficiency in working with Linux OS is a must.
• Robotics Platforms: Familiarity with platforms like ROS, ROS 2, or similar.

• Experience:
• Proven experience in software quality assurance, preferably in the medical device or surgical robotics domain.
Experience in writing clear, concise, and comprehensive test plans and test cases.

• Knowledge:
• Must be familiar with medical device regulations and standards. Examples include: IEC 62304, ISO 14971, ISO 13485, TIR57, TIR97.
• Must be familiar with software QA tools (e.g., Greenlight Guru), methodologies, and processes.
• Proficiency with tools like Git/JIRA/Confluence and platforms like GitHub.

• Soft Skills:
• Strong analytical, problem-solving, and organizational abilities.
Good communication skills to collaborate with interdisciplinary teams, including software engineers, hardware engineers, and product managers.

• Other Requirements:
• Capable of occasionally lifting and/or moving robotics equipment.
• Ability to handle delicate robotic components and tools.
• Comfortable working in a lab or workshop environment alongside surgical robotic systems.

• Responsibilities:
• Regulatory Compliance and Safety:
• Ensure all software testing activities are compliant with medical device standards and regulations (e.g., IEC 62304, ISO 14971, ISO 13485).
• Prioritize and advocate for patient safety during all phases of software development and testing.
• Assist in the preparation of documentation and evidence for regulatory submissions and audits.
• Test Development and Execution:
• Design, develop, and execute manual and automated test cases, test plans, and test scripts for various robotic functionalities, including movement, control systems, sensors, and software integrations.
• Identify, analyze, and document software defects, inconsistencies, and enhancements.
• Execute regression tests, functional tests, and stress tests.
• Collaboration:
• Work closely with the software development team to understand the architectural design and specific functionalities.
• Coordinate with the hardware team to integrate software-hardware testing.
• Collaborate with product managers and stakeholders to understand and define product requirements and specifications.
• Process Improvement:
• Work with software lead in the development and improvement of software QA processes, methodologies, and tools.
• Champion the integration of new testing tools and methodologies tailored for surgical robots.
• Documentation:
• Document detailed steps for reproducing reported software anomalies and defects.
• Maintain QA log and issue tracker to keep track of reported defects and their resolution status.
• Generate QA metrics and reports to highlight the software's quality and areas for improvement.

This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology.