Senior Software QA Engineer I

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

Why Merit?

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.

WORK SHIFT

DAY (United States of America)

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.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Reading
• Field of vision/peripheral

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

COMMENTS

Infectious Control Risk Category III:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

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

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.