Senior Software QA Engineer I
Merit Medical Systems, Inc. · South Jordan, UT · 2 mo ago
EngineeringFull-time
Summary Of Duties
- Ensures software meets highest standards of safety, reliability, and regulatory compliance.
- Partners across departments to ensure software aligns with design control, risk management, and post-market surveillance expectations.
- 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.
- Led software risk analysis (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities.
- Reviews and approves protocols, traceability matrices, and reports.
- Evaluates and qualifies software suppliers (audits, risk-based assessments).
- Leads investigations for software-related issues and field events.
- Safeguards robust change management, impact analysis, and regression strategies.
- Supports vulnerability management, secure design, and patching strategies.
- Performs trending, field analysis, and risk updates for released software.
Essential Physical/Environmental Demands
- Lifting -- Not to exceed 50 lbs. – local practice may apply.
- 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 / QMSRFDA 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.