Product Systems Engineer
Are you passionate about delivering excellence and making a real impact? Do you thrive on applying sharp analytical skills, innovative thinking, and technical expertise to meaningful challenges? If so, we invite you to explore an exciting opportunity with us.
VISIE is a dynamic medical device startup in Austin, Texas, pioneering a computer vision platform that redefines surgical navigation and robotics. Our technology integrates real-time, pinpoint-accurate 3D surface measurements into clinical workflows, enhancing how preoperative CT and MRI data are used during surgery for greater precision and decision-making.
Join our close-knit team of experts and help shape the future of the digital operating room, improving outcomes for millions of patients worldwide.
To apply, send your resume and cover letter to
What You Will Be Doing
System Ownership: Own the system-level architecture from initial requirements through final validation, ensuring all components (hardware, software, mechanics) align to clinical and regulatory needs.
Requirements Definition: Develop and maintain complete system requirements, including functional, performance, safety, and usability specifications.
Risk Management: Lead risk analysis (ISO 14971) activities for the integrated product, working collaboratively across disciplines to anticipate and mitigate risks.
System Performance Requirements: Define and validate system-level requirements for latency, data throughput, and real-time behavior, ensuring alignment across hardware, firmware, and software teams.
Validation & Verification Planning: Write, review, and execute test protocols that demonstrate the system meets clinical and technical requirements.
Design Controls & Compliance: Maintain traceability of requirements, risk analyses, and verification evidence in accordance with ISO 13485 design controls.
Cross-Functional Collaboration: Act as a bridge between software, hardware, integration, and mechanical teams to ensure coherent system behavior.
Customer & Demo Engagement: Support customer-facing demos, cadaver labs, and early user evaluations to validate system performance and usability.
Required Skills, Education, and Experience
Education: Bachelor's or master's degree in Mechanical, Electrical, Systems, Biomedical, or a related engineering field.
System Engineering Skills: 3+ years working on cross-disciplinary systems involving hardware, software, and mechanical integration.
Medical Device Experience: Familiarity with ISO 13485, ISO 14971, and design control practices.
Requirements & Risk Management: Skilled at authoring and managing requirements and performing risk analyses.
Validation and Verification: Experience planning and executing system-level V&V activities.
Strong Communication: Ability to work across teams, translate technical needs into system requirements, and clearly document complex decisions.
Ways to Stand Out
Familiarity with Real-Time Systems: Understanding of embedded hardware/software interaction, DMA-based data flows, and performance optimization considerations is a plus.
Medical Robotics or Surgical Navigation: Experience with surgical robotics, navigation systems, or medical imaging.
Startup Experience: Comfortable working in a fast-paced environment with evolving priorities.
Hands-On System Testing: Direct experience supporting lab tests, system troubleshooting, or customer demos.