Sobre este puesto de Senior Quality Engineer en Rapidai
As a Senior Quality Engineer at RapidAI, you will serve as an essential guardian of patient safety, compliance, and product excellence across our industry-leading Software as a Medical Device (SaMD) portfolio. You will embed directly with Engineering, Clinical, and Product teams to ensure our cutting-edge AI diagnostic and workflow solutions meet the highest standards of safety, efficacy, and regulatory compliance from initial concept through global release.
In this role, you will champion robust design controls, lead risk management initiatives, oversee verification and validation (V&V) activities, and continuously refine our Quality Management System (QMS). Working in an agile, AI-first environment, you understand that rapid product iteration must go hand-in-hand with uncompromising regulatory rigor (IEC 62304, ISO 13485, ISO 14971, and FDA QMSR / 21 CFR Part 820).
Work Location:This role requires a hybrid work location arrangement. You will be required and expected to be present and work in the Golden office (1120 Washington Ave, Golden,CO 80401)up to 3 days per week, and as needed for department or functional project meetings. On days when you are not required to be in the office, you will have the flexibility to work remotely, subject to the needs of the team and business.
How You Help Us Grow!
Position Duties and Responsibilities:
- Lead Software Quality Assurance for SaMD: Establish, implement, and maintain software quality engineering processes across the complete software development life cycle (SDLC) in alignment with IEC 62304, ISO 13485, and FDA regulations.
- Design Controls & Requirement Traceability: Review and evaluate software product requirements, architecture specifications, and user stories to ensure complete bidirectional traceability, objective testability, and appropriate risk mitigations.
- Risk Management Leadership: Drive product risk analysis in accordance with ISO 14971, ensuring that software hazards, failure modes (dFMEA), and risk controls are systematically identified, mitigated, and verified.
- Verification & Validation (V&V) Oversight: Review, audit, and approve software test plans, automated and manual test protocols, V&V execution reports, and clinical evaluation deliverables to guarantee compliance with global regulatory submissions.
- Defect & Deviation Management: Oversee and track software problem reports, anomalies, bug escalations, and non-conformances from triage through root cause analysis (RCA), corrective actions, and verified closure.
- Test Tool & Automated Infrastructure Validation: Support the development, update, validation, and documentation of internal and third-party software tools utilized in testing and qualifying SaMD (CSV / Software Tool Validation according to ISO/TR 80002-2).
- Cross-Functional Quality Partnership: Act as the primary Quality Engineering liaison to R&D, Platform Engineering, Clinical Affairs, and Regulatory, advising teams on design controls without impeding sprint momentum.
- Continuous QMS Enhancement: Participate in internal audits, support external regulatory audits (FDA, Notified Bodies/MDR), and drive continuous improvements across our quality management procedures.
What You Bring!
Required Qualifications:
- Experience: 5+ years of software quality engineering experience within the medical device, digital health, or life sciences industry.
- Education: Bachelor of Science degree in Biomedical Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline.
- SaMD & Standards Expertise: In-depth, hands-on working knowledge of Software as a Medical Device (SaMD) standards including IEC 62304 (Medical Device Software Life Cycle Processes), ISO 13485, ISO 14971 (Risk Management), and FDA 21 CFR Part 820 / QMSR.
- Design Controls & Traceability: Demonstrated track record managing end-to-end design history files (DHF), requirement traceability matrices (RTM), risk documentation, and V&V reports for commercial releases.
- Problem Solving & Root Cause Analysis: Proven experience managing software defect lifecycles, CAPA, non-conformances, and driving rigorous root cause investigations with engineering teams.
- Communication & Collaboration: Outstanding written and verbal communication skills; ability to hold cross-functional collaborators accountable to strict delivery milestones while maintaining collaborative, trusted relationships.
- Results-Driven: Relentless attention to detail with the ability to thrive under tight sprint cycles and shifting priorities in a high-growth environment.
- Clinical AI & Machine Learning: Experience qualifying or testing AI/ML-based algorithms, computer vision pipelines, or diagnostic decision support software.
- Cloud & Agile Environments: Familiarity with modern cloud-native architectures (AWS), CI/CD automated validation pipelines, and Agile/Scrum development methodologies.
- Tool Validation: Direct experience with Software Tool Validation (CSV) under ISO/TR 80002-2, including validation of ALM/QMS tools such as Jira, GitHub, Propel, or TestRail.
- Regulatory Submissions: Direct experience participating in FDA 510(k), De Novo, or EU MDR technical documentation submissions and external audits.
- Certifications: ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE).
Preferred Qualifications:
