Senior Quality Engineer (Independent Contractor)

United States·GoldenFull Time - Contractorsenior

EngineeringQuality Engineer

1 views0 saves0 applied

Apply Now

Quick Summary

Overview

RapidAI is the trusted leader in deep clinical AI, helping hospitals deliver faster, more informed care through intelligent imaging and integrated workflows.

Technical Tools

project-management

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

Software as a Medical Device (SaMD) New Product Development Support: Provide Software Quality Engineering support for the development of new SaMD projects. This includes defining a Design and Development Plan with the core team in alignment with Design Controls (per ISO 13485, 21CFR820, and MDSAP country specific requirements), completion of QE deliverables, and Project Management of the core team to facilitate the approval/clearance of the Software as a Medical Device (SaMD) within designated markets.

Quality Frameworks: Develop, implement, and maintain standards for software quality processes and procedures to support the software life cycle in alignment with IEC 62304.

Compliance Oversight: Ensure that software project and process control documentation are compliant with relevant regulations and associated internal procedures.

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 defects to closure and support sustaining design changes per Design Controls.

Tool & Test Validation: Support the development, update, and validation of software utilized in SaMD development, testing, and deployment.

Systems Integration: Support new product development activities specifically utilizing the Jama requirements management platform

The Contractor is expected to possess the following professional background:

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 working within a Quality Management Systems (QMS) and development of an SaMD 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.

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.

Please review our CPRA policies here.

For more information on the information we collect about our applicants and how we use it, see our CPRA Privacy Notice here.