Senior Quality Engineer (Med Device/SaMD)

Jobs via Dice; Mounds View (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

A leading company in digital health is seeking a Senior Quality Engineer to provide quality engineering leadership for web, mobile, and AWS-based applications. The role involves ensuring compliance with regulatory standards, managing risk, and driving software quality throughout the development lifecycle. Ideal candidates will have a strong background in software quality engineering and experience in medical devices.

Qualifications

• Minimum 4 years of technical experience, or advanced degree with 2 years of technical experience.
• Experience in SaMD and cloud-based medical software preferred.

Responsibilities

• Provide technical leadership in software quality engineering for Digital Health and SaMD products.
• Ensure compliance with global medical device regulations and standards.
• Lead software risk management activities and ensure robust cybersecurity measures.

Skills

Risk Management

Software Quality Engineering

Regulatory Compliance

Cybersecurity

Process Improvement

Education

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

Job description

Senior Quality Engineer (Med Device/SaMD)

Senior Quality Engineer (Med Device/SaMD)

1 day ago Be among the first 25 applicants

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

Job Description:

As a Senior 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.

Responsibilities

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:

• 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

  Quality Assurance

• Industries

  Software Development

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

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

Senior Design Quality Engineer - Peripheral Interventions

Senior Electrical Engineer | Project Manager

Minneapolis, MN $110,000.00-$150,000.00 2 months ago

Minnetonka, MN $75,300.00-$150,700.00 8 months ago

Minneapolis, MN $91,506.00-$123,532.00 6 days ago

Minnetonka, MN $50,000.00-$100,000.00 2 months ago

Quality Engineer (Hybrid - Maplewood, MN)

Maplewood, MN $119,076.00-$145,537.00 1 week ago

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