The Role
The role involves developing quality frameworks, ensuring compliance, managing SaMD support, technical reviews, and tracking software problem reports.
Summary Generated by Built In
RapidAI is the trusted leader in deep clinical AI, helping hospitals deliver faster, more informed care through intelligent imaging and integrated workflows. The Rapid Enterprise™ Platform supports disease states across the care spectrum, but it’s our clinical depth that drives the most meaningful impact — improving decision-making, patient outcomes, and health-system performance. Used by more than 2,500 hospitals in over 100 countries and backed by 700+ clinical studies, including research that helped expand national stroke-treatment guidelines, RapidAI is the most clinically validated AI platform in healthcare.
We are seeking an Independent Contractor to provide Senior Quality Engineering services at the forefront of medical device software development.
- Engagement Type: Independent Contractor (Project-Based)
- Schedule: Full-time hours (approx. 40 hrs/week)
- Duration: 3–6 Month Term
- Location: On-site at Golden, CO office (Denver area) 2-3 days a week
Scope of Services
- Quality Frameworks: Develop, implement, and maintain standards for software quality processes and procedures to support the software life cycle.
- Compliance Oversight: Ensure that software project and process control documentation are compliant with established procedures.
- SaMD Support: Provide Software Quality Assurance support for Research and Development and production of Software as a Medical Device (SaMD).
- Technical Reviews: Review product requirements for traceability, risk remediation, and testability.
- Regulatory Compliance: Review verification and validation deliverables for compliance with regulatory requirements.
- Issue Tracking: Manage and track software problem reports and deviations through to closure.
- Tool & Test Validation: Support the development, update, and validation of software utilized in SaMD testing.
- Systems Integration: Support new product development activities specifically utilizing the Jama requirements management platform
Qualifications and Experience
- Educational Background: Bachelor of Science Degree.
- Technical Experience: 5+ years of professional experience preferred, including a mandatory background in Software Development.
- Specialized Knowledge: Previous experience with Quality Management Systems (QMS) and SaMD development under IEC 62304 is preferred.
- Platform Proficiency: Prior experience using Jama Connect for requirements and traceability is strongly preferred.
- Professional Skills: Strong project management skills , results-driven approach , and the ability to maintain accountability to strict project deadlines.
The Contractor is expected to possess the following professional background:
Join our mission to help save lives and shape the future of healthcare—we look forward to hearing from you!
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Skills Required
- Bachelor of Science Degree
- 5+ years of professional experience
- Background in Software Development
- Experience with Quality Management Systems and SaMD development under IEC 62304
- Experience using Jama Connect for requirements and traceability
- Strong project management skills
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The Company
What We Do
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. Leading the next evolution of clinical decision-making and patient workflow, RapidAI is empowering physicians to make faster decisions for better patient outcomes. Based on intelligence gained from over 5 million scans in more than 2,000 hospitals in over 60 countries, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible. RapidAI — where AI meets patient care.
