Senior Software QA Engineer I
Merit Medical Systems•South Jordan, UT
•Onsite
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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; 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.
Benefits
- Medical/Dental & Other Insurances
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
