Senior Quality Engineer

RapidAI•Golden, WA

3d•Hybrid

About The Position

RapidAI is hiring a Senior Quality Engineer to help ensure patient safety, regulatory compliance, and product excellence across its Software as a Medical Device (SaMD) portfolio. The role works directly with Engineering, Clinical, Product, Platform Engineering, and Regulatory teams to ensure AI diagnostic and workflow products meet safety, efficacy, and regulatory requirements from concept through global release. The Senior Quality Engineer leads software quality engineering and design-control activities across the software development life cycle, manages product risk, and oversees verification and validation. The role also supports the ongoing improvement of RapidAI’s Quality Management System in an agile, AI-focused environment, balancing rapid iteration with regulatory rigor under IEC 62304, ISO 13485, ISO 14971, and FDA QMSR / 21 CFR Part 820. This is a hybrid role based at RapidAI’s Golden, Colorado office. The employee is expected to work in the office up to three days per week and as needed for department or functional project meetings; remote work is available on other days, subject to team and business needs.

Requirements

At least 5 years of software quality engineering experience in the medical device, digital health, or life sciences industry.
Bachelor of Science degree in Biomedical Engineering, Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline.
In-depth, hands-on working knowledge of SaMD standards, including IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / QMSR.
Demonstrated experience managing end-to-end design history files, requirement traceability matrices, risk documentation, and verification and validation reports for commercial releases.
Experience managing software defect lifecycles, CAPA, and non-conformances, and conducting rigorous root cause investigations with engineering teams.
Strong written and verbal communication skills and the ability to hold cross-functional collaborators accountable to delivery milestones while maintaining collaborative relationships.
Strong attention to detail and ability to work under tight sprint cycles and shifting priorities in a high-growth environment.
Must be currently authorized to work in the United States without restriction; visa sponsorship is not available.

Nice To Haves

Experience qualifying or testing AI/ML algorithms, computer vision pipelines, or diagnostic decision-support software.
Familiarity with cloud-native architectures such as AWS, CI/CD automated validation pipelines, and Agile/Scrum development.
Direct experience with Software Tool Validation under ISO/TR 80002-2, including validation of ALM/QMS tools such as Jira, GitHub, Propel, or TestRail.
Experience participating in FDA 510(k), De Novo, or EU MDR technical documentation submissions and external audits.
ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE).

Responsibilities

Establish, implement, and maintain software quality engineering processes across the complete software development life cycle in alignment with IEC 62304, ISO 13485, and FDA regulations.
Review software product requirements, architecture specifications, and user stories to ensure bidirectional traceability, objective testability, and appropriate risk mitigations.
Lead product risk analysis in accordance with ISO 14971, including identification, mitigation, and verification of software hazards, failure modes, and risk controls.
Review, audit, and approve software test plans, automated and manual test protocols, verification and validation execution reports, and clinical evaluation deliverables.
Oversee software problem reports, anomalies, bug escalations, and non-conformances from triage through root cause analysis, corrective actions, and verified closure.
Support development, updates, validation, and documentation of internal and third-party software tools used to test and qualify SaMD.
Serve as the Quality Engineering liaison to R&D, Platform Engineering, Clinical Affairs, and Regulatory, advising on design controls while supporting sprint progress.
Participate in internal audits, support external regulatory audits, and drive continuous improvement of quality management procedures.