Software-QA-Engineer-Software as a Medical Device

Jobs via Dice; Mounds View (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in digital health is seeking a Senior Software Quality Engineer to provide quality assurance for software as a medical device. This role involves ensuring compliance with regulatory standards, managing risk, and collaborating with various teams to enhance software quality. Candidates should have a relevant degree and experience in software quality engineering, particularly in regulated environments.

Qualifications

• Minimum of 4 years of technical experience, or advanced degree with 2 years of technical experience.
• Experience with SaMD, cloud-based medical software, or mobile health apps is a plus.

Responsibilities

• Provide quality engineering leadership for web, mobile, and AWS-based applications.
• Ensure compliance with global regulatory standards and manage risk and cybersecurity.
• Collaborate with R&D, Regulatory Affairs, and Systems Engineering to deliver compliant solutions.

Skills

Risk Management

Software Quality Assurance

Regulatory Compliance

Cybersecurity

Education

Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, or related field

Job description

Software-QA-Engineer-Software as a Medical Device

Software-QA-Engineer-Software as a Medical Device

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Dice is the leading career destination for tech experts at every stage of their careers. Our client, VetForce Solutions, is seeking the following. Apply via Dice today!

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Software Development

Referrals increase your chances of interviewing at Jobs via Dice by 2x

Sign in to set job alerts for “Software Quality Assurance Engineer” roles.

Senior Software Quality Assurance Engineer (QA)

Senior Software QA Engineer - Digital Health -CRDN

Principal Systems Software Engineer - Jet Engine Test Cells

Manager, Quality Assurance Engineer AI/ML

System Test Automation Engineer - LabVIEW

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.