Senior Software QA Engineer I

Regulatory Toolkit; South Jordan (UT); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Medical/Dental & Other Insurance (elig

Onsite medical clinic

Cafeterias on site

Paid holidays and vacation

401K

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Software assurance

Regulated software

Regulatory knowledge

FDA/IEC knowledge

Ausbildung

Bachelor's degree in engineering

Tools

Jira

Monday.com

Jobbeschreibung

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

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