Senior Medical Device Software QA Engineer

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

Benefits offered by this job

Medical/Dental & Other Insurances

Low Cost Onsite Medical Clinic

Onsite Cafeterias

Vacation, Sick-Time & Holidays

401K

Job summary

Merit Medical in Utah is seeking an experienced software quality assurance professional to ensure that software used in medical devices and manufacturing systems meets safety, reliability, design controls, risk management, and post-market surveillance expectations.

You will collaborate across departments, lead risk analyses, qualify suppliers, and drive changes with robust validation, traceability, and compliance to 21 CFR 820, ISO 13485, and IEC 62304.

Qualifications

• Bachelor’s degree in relevant engineering discipline.
• Eight+ years in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, 21 CFR Part 820 / QMSR.
• FDA software validation and CSA guidance.
• Experience with Jira and Monday.com.
• Ability to interpret architecture, code structure, and test coverage.

Responsibilities

• Develops and maintains software quality plans aligned with design controls and regulatory requirements.
• Ensures compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
• Leads software risk analysis (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities.
• Reviews protocols, traceability matrices, and reports for clarity and testability.
• Evaluates and qualifies software suppliers; conducts audits and risk assessments.
• Leads investigations for software-related issues and field events.
• Supports change management, impact analysis, and regression strategies.

Skills

Software assurance

Regulated software development

Education

Bachelor’s degree in relevant engineering discipline

Tools

Jira

Monday.com

Job description

Merit Medical in Utah is seeking an experienced software quality assurance professional to ensure that software used in medical devices and manufacturing systems meets safety, reliability, design controls, risk management, and post-market surveillance expectations.

You will collaborate across departments, lead risk analyses, qualify suppliers, and drive changes with robust validation, traceability, and compliance to 21 CFR 820, ISO 13485, and IEC 62304.