Sr. Software Defect Investigation Engineer - Medical devices

Location: Raleigh, NC | Duration: 6 Months | Hybrid: 3 Days Onsite

1. Product Defect Investigation & Root Cause Analysis – Experience investigating software/product defects, determining root causes, assessing severity and impact, and defining reproducible steps.

2. JIRA Issue & Defect Management – Hands-on experience managing defect records, coordinating issue triage, documenting investigations, and maintaining accurate, auditable records in JIRA.

3. Risk Management & Quality Compliance – Experience assessing product risks, documenting risk impacts, identifying gaps in risk management files, and escalating safety-critical issues.

4. Cross-Functional Project Coordination – Ability to coordinate with Software Engineering, Quality Assurance, Regulatory Affairs, Systems Engineering, and other stakeholders to drive investigations and meet deadlines.

5. Regulated Industry Experience – Experience in medical devices, pharmaceuticals, automotive, or another regulated industry, with knowledge of quality processes, requirements, and testing.

Recruiter's sourcing priorities

• Experience: 5+ years in engineering, product support, systems engineering, quality engineering, or software defect management.
• Tools: JIRA and Microsoft Office.
• Domain: Medical devices is particularly relevant; prioritize candidates familiar with product risk and safety-critical issues.
• Education: Bachelor's degree in Engineering or a related field, or equivalent experience.

Best candidate titles to search: System Engineer, Product Quality Engineer, Systems Quality Engineer, Software Quality Engineer, Product Support Engineer, or Systems Engineer – Defect & Risk Management.

Important: This role is more focused on product defect investigations, risk assessment, and quality documentation than traditional infrastructure or IT systems engineering.