Senior Software QA Engineer - Regulated Medical Devices

Merit-Medical-Systems-Inc.; South Jordan (UT); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Onsite Clinic

Cafeterias

Job summary

Merit Medical Systems, Inc. in the United States is seeking a Software Quality Assurance professional to ensure software across devices and manufacturing systems meets safety and regulatory standards.

You will lead risk analyses, review validation protocols, and manage supplier quality with a focus on secure design and post-market surveillance. 8+ years in regulated software is desired.

Qualifications

• Bachelor's degree in an engineering discipline with 8+ years in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820 / QMS.
• Experience with requirements/tools such as Jira and Monday.com; ability to interpret architecture and test coverage.
• Experience with Class II/III medical devices and AI/ML in regulated environments preferred.

Responsibilities

• Leads software risk analysis (FMEA, hazard analysis) and CSA risk activities.
• Reviews and approves protocols, traceability matrices, and reports for clarity and testability.
• Evaluates and qualifies software suppliers through audits and risk-based assessments.
• Leads investigations for software-related issues and field events.
• Ensures robust change management, impact analysis, and regression strategies.
• Partners on vulnerability management, secure design, and patching strategies.
• Supports trending, field analysis, and risk updates for released software.

Skills

Software assurance

Regulated software development

Risk analysis (FMEA)

Regulatory standards knowledge

Communication skills

Education

Bachelor’s degree in engineering

Tools

Jira

Monday.com

Job description

Merit Medical Systems, Inc. in the United States is seeking a Software Quality Assurance professional to ensure software across devices and manufacturing systems meets safety and regulatory standards.

You will lead risk analyses, review validation protocols, and manage supplier quality with a focus on secure design and post-market surveillance. 8+ years in regulated software is desired.