Overview
Skills
Job Details
Senior-Software-QA-Engineer
Exp: 5 - 10 Years
Mounds View, MN
Onsite Role
Long Term Project
Some more Information:
Job Description:
As a Senior Software Quality Engineer Digital Health, you ll provide quality engineering leadership for web, mobile, and AWS-based cloud applications, including SaMD platforms. You will ensure compliance with global regulatory standards, manage risk and cybersecurity, and champion software quality throughout the development lifecycle.
You ll collaborate closely with R&D, Regulatory Affairs, and Systems Engineering to deliver reliable, secure, and compliant digital health solutions.
In general, the following responsibilities apply for the role. This includes, but is not limited to the following:
Software Design Assurance Leadership Provide technical leadership in software quality engineering for Digital Health (DH) and Software as a Medical Device (SaMD) product within the Coronary and Renal Denervation (CRDN) business.
Regulatory Compliance & Standards Ensure compliance with global medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and applicable AI/ML regulations.
Risk Management & Cybersecurity Lead software risk management activities per ISO 14971 and IEC 81001-5-1, ensuring robust hazard analysis, risk controls, and cybersecurity measures for DH/SaMD solutions.
Software Development Lifecycle (SDLC) Oversight Provide quality oversight for software development, verification, validation, and release activities, ensuring adherence to Client s design control processes.
AWS-Based Web & Mobile Application Assurance Drive software design assurance activities for AWS-based cloud applications and mobile apps, ensuring compliance with software development best practices, cloud security, and regulatory requirements for SaMD.
Design Control & Quality Engineering Ensure rigorous software design control activities, including requirements review, design verification, validation planning, and defect tracking, to enhance software quality and reliability.
Digital Health & AI/ML Assurance Support assurance activities for AI/ML-enabled medical software, ensuring proper data integrity, algorithm validation, and continuous learning risk controls.
Process Improvement & QMS Enhancements Contribute to the advancement of Client s Software Quality Management System (QMS), focusing on process efficiency, compliance, and best practices in digital health.
Audits & Compliance Readiness Support internal and external audits (e.g., FDA, Notified Body, MDSAP), ensuring software quality documentation and evidence meet regulatory expectations.
Training & Mentorship Act as a subject matter expert (SME) in software quality, providing training and mentorship to engineers and stakeholders on best practices in SaMD, cloud-based software quality, and digital health applications.
MUST HAVE - MINIMUM REQUIREMENTS:
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON CANDIDATE s RESUME
Bachelor s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
Minimum of 4 years of technical experience, or advanced degree with 2 years of technical experience
Nice to Have:
SaMD, cloud-based medical software, mobile health apps
Health Software
Design Control / Design Assurance
Risk Management, traceability, requirements reviews
Verification & Validation Oversight (not test execution)
Audit support, regulatory submissions, technical file reviews
QMS or Quality Engineering experience in regulated environments.