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 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
COMMENTSInfectious 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.
