Senior Software QA Engineer I

Merit Medical Systems, Inc.; South Jordan (UT); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Onsite Medical Clinic

Paid Vacation

Sick Time

Paid Holidays

401K

Health Savings Account

Job summary

Merit Medical Systems, Inc. is seeking an experienced software assurance professional to ensure safety, reliability, and regulatory compliance of software across medical devices and manufacturing systems. The role partners with multiple departments to meet design controls and post-market expectations.

The candidate will lead software risk analyses, review protocols and reports, qualify software suppliers, and drive change management and secure design initiatives across the organization.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 8+ 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 requirements/tools (e.g., Jira, Monday.com).
• Ability to interpret architecture, code structure, and test coverage.

Responsibilities

• Develops and maintains software quality plans aligned with design controls and global 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 and approves protocols, traceability matrices, and reports; ensure clarity 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.

Skills

Software assurance

Regulated software

Design controls

Risk analysis

Requirements analysis

Architecture understanding

Documentation & testing

Education

Bachelor's degree in engineering

Tools

Jira

Monday.com

Job description

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Summary Of Duties

Ensures that software used in Merit medical devices, manufacturing systems, and supporting digital platforms meets the highest standards of safety, reliability, and regulatory compliance. Partners closely across departments to ensure that all software—embedded, application-level, cloud, or manufacturing-related—meets design control, risk management, and post-market surveillance expectations.

Essential Functions Performed

• Develops and maintains software quality plans aligned with design controls and global 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 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.

Summary Of Minimum Qualifications

• Education and/or experience equivalent to a Bachelor’s degree in relevant engineering discipline.
• A minimum of eight (8) years of experience 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 requirements/tools (e.g., Jira, Monday.com)
• Ability to interpret architecture, code structure, and test coverage

Preferred Qualifications

• Experience in Class II or Class III medical devices.
• Experience with AI/ML in regulated environments.
• Experience with cyber-security standards (e.g., UL 2900).
• Certifications such as ASQ CSQE, ISTQB, Certified Quality Engineer (CQE)
• Experience in independently performing Advanced Operations or manufacturing software validation.

COMPETENCIES

• Interpersonal skills
• Organization
• Written and Verbal Communication
• Problem Solving

As an eligible Merit employee, you can expect the following:

• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.