JOB SUMMARY
The Principal Software Engineer will take a lead role in the development of advanced medical device software for surgical planning and intra-operative guidance in spinal procedures as part of a computer-aided surgery system. This role demands deep technical expertise in the entire technology stack and the ability to guide architectural evolution to support future development needs. The Principal Software Engineer will work collaboratively within cross-functional teams, mentoring engineers and refining processes across multiple teams to ensure high-quality and regulatory-compliant solutions.
DUTIES AND RESPONSIBILITIES
- Lead the design, development, and optimization of software algorithms and applications, specifically in medical image segmentation, registration, visualization, and procedural planning for spinal surgeries.
- Drive the evolution of the software architecture to accommodate new system requirements and ensure scalable, maintainable code.
- Oversee the development of pre-operative and intra-operative user interfaces, enhancing usability and functionality based on surgical team feedback.
- Define and document requirements and design specifications in collaboration with regulatory, quality, and marketing specialists.
- Mentor software engineering team members, providing guidance on best practices, technical issues, and regulatory documentation.
- Collaborate with cross-functional teams to refine development processes and ensure that all software life cycle documentation adheres to FDA and ISO standards.
- Engage with surgeons and medical advisors to understand clinical needs and integrate feedback into the software design process.
- Lead the creation of comprehensive documentation throughout the software life cycle, from project planning to deployment.
EXPERIENCE AND QUALIFICATIONS
- Education: Master’s degree in Computer Science or related field with 10+ years of software development experience, or a Bachelor’s degree with 12+ years of relevant experience.
- Technical Expertise: Proven mastery in medical image processing, computational geometry, computer graphics, and surface meshing.
- Programming Skills: Extensive experience with object-oriented programming in a .NET environment (C++/C#).
- Regulatory Knowledge: Experience with FDA-regulated products and knowledge of ISO quality standard, IEC 62304. Experience leading teams in a regulated software development environment.
- Communication: Excellent verbal and written communication skills, with a demonstrated ability to work collaboratively across technical and non-technical teams.
- Leadership: Proven track record of mentoring engineers and agile methodologies across teams that enhance software quality and team productivity.
Contact: careers@onpointsurgical.com