Principal Medical Software Quality Assurance Engineer

Open Position –  Principal Medical Software Quality Assurance 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.

We are seeking a highly experienced Medical Product Software Quality Assurance Engineer in the principal level who will lead Horizon’s medical device software quality assurance and testing. 
In this role, you will work as a senior member in the medical software developing R&D group. You will lead the software testing engineers, plan the software testing objectives/resources/schedule together with the product managing group, and report the testing results and overall software quality to management. You will report to the VP of Software Engineering. 

Responsibilities:

• Medical Software Test Strategical Planning:  Based on the standards (IEC 62304, software development lifecycle management, ISO 13485, overall quality management system, ISO 14971, risk management), you will plan, execute and report the entire software testing activities. 
• Leading and Collaboration: You will work with other software testing engineers, system testing engineers, software development groups, and hardware development groups. You will have to lead the software testing engineers while collaborating with multiple R&D groups to plan and execute the testing. 
• Quality Assurance and Compliance: You will lead the effort of producing the medical software quality assurance related documents and will make sure to deliver the deliverables of documents on time for each checkpoint of development stages. 
• Defect Management and Accurate Status Reporting: You will be in charge of creating, updating, and running review of defects with DRB (defect review board) members. 

Qualifications and experience

• 8+ years of experience in medical software quality assurance and software testing. 
• Strong understanding of the medical software QA methodologies, tools, processes.
• Experience in at least one round of software product development life cycle, and delivering all SW QA documents of each software lifecycle stage, from defining product to post SW release.
• Ability to work with cross-functional projects, planning and executing the testing, and resolving issues from the execution of testing. 
• Strong communication and collaboration skills. 
• Experience in transforming the manual test cases and procedure to automated testing. 

Work location:

• You will be required to work in either Santa Monica or Malibu, 100% on site, due to the device hardware access. 
• You will have to travel less than 10% of your time. 

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