Senior Software QA Engineer - Regulated Medical Devices

Regulatory Jobs; South Jordan (UT); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/Dental & Other Insurance (elig

Onsite medical clinic

Cafeterias on site

Paid holidays and vacation

401K

Job summary

Merit Medical seeks a seasoned Software Assurance professional to ensure software across devices, manufacturing, and digital platforms meets safety, reliability, and regulatory standards. The role collaborates cross-functionally to align with design controls, risk management, and post-market surveillance expectations.

Applicants should bring eight+ years in regulated software, strong IEC/ISO knowledge, and experience with Jira and FDA validation. On-site in Utah with diverse shifts offered.

Qualifications

• Bachelor's degree in an engineering discipline.
• At least 8 years in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, 21 CFR 820 / QMSR.
• Experience with Jira or Monday.com and FDA software validation.

Responsibilities

• Develops and maintains software quality plans aligned with design controls.
• Ensures compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
• Leads software risk analyses (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities.
• Reviews and approves protocols, traceability matrices, and reports; requirements for clarity, completeness, and testability.
• Evaluates and qualifies software suppliers (audits, 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.
• Performs other duties, as assigned.

Skills

Software assurance

Regulated software

Regulatory knowledge

FDA/IEC knowledge

Education

Bachelor's degree in engineering

Tools

Jira

Monday.com

Job description

Merit Medical seeks a seasoned Software Assurance professional to ensure software across devices, manufacturing, and digital platforms meets safety, reliability, and regulatory standards. The role collaborates cross-functionally to align with design controls, risk management, and post-market surveillance expectations.

Applicants should bring eight+ years in regulated software, strong IEC/ISO knowledge, and experience with Jira and FDA validation. On-site in Utah with diverse shifts offered.