Senior Software QA Engineer I

Merit-Medical-Systems-Inc.; South Jordan (UT); Vor Ort; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Onsite Clinic

Cafeterias

Zusammenfassung

Merit Medical Systems, Inc. in the United States is seeking a Software Quality Assurance professional to ensure software across devices and manufacturing systems meets safety and regulatory standards.

You will lead risk analyses, review validation protocols, and manage supplier quality with a focus on secure design and post-market surveillance. 8+ years in regulated software is desired.

Qualifikationen

• Bachelor's degree in an engineering discipline with 8+ years in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820 / QMS.
• Experience with requirements/tools such as Jira and Monday.com; ability to interpret architecture and test coverage.
• Experience with Class II/III medical devices and AI/ML in regulated environments preferred.

Aufgaben

• Leads software risk analysis (FMEA, hazard analysis) and CSA risk activities.
• Reviews and approves protocols, traceability matrices, and reports for clarity and testability.
• Evaluates and qualifies software suppliers through audits and 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.

Kenntnisse

Software assurance

Regulated software development

Risk analysis (FMEA)

Regulatory standards knowledge

Communication skills

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 SHIFTDAY (United States of America)SUMMARY OF DUTIESEnsures 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 PERFORMEDDevelops 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 activitiesReviews 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/peripheralSUMMARY OF MINIMUM QUALIFICATIONSEducation 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 guidanceExperience with requirements/tools (e.g., Jira, Monday.com)Ability to interpret architecture, code structure, and test coveragePREFERRED QUALIFICATIONSExperience 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 SolvingCOMMENTSInfectious 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 AccountTo see more on our culture, go to www.merit.com/careers .Military Veterans are encouraged to Apply.Merit is a proud Utah Patriot Partner committed to hiring our Veterans.