Systems Engineer - Medical Device

Job Title: Systems Engineer - Medical Device

Company: Novozen Healthcare LLC

Location: Raleigh, NC (Hybrid – 3 Days On-site, 2 Days Remote)

Employment Type: Contract (6 Months+, with Potential Extension)

Job Responsibilities:

• Own and coordinate software backlog management for one or more related products, supporting new product development, maintenance, and engineering activities.
• Lead investigations into reported product defects and collaborate with subject matter experts to identify root causes.
• Assess the cause, impact, and severity of product issues, including affected users, interfacing systems, frequency, and software versions.
• Define reproduction steps for identified issues and document existing mitigations.
• Evaluate risks associated with unresolved issues and escalate gaps in risk management documentation to the appropriate risk owners.
• Coordinate issue triage, identify duplicate records, document closure rationales, and ensure unique anomalies proceed through investigation.
• Maintain accurate, complete, and auditable issue records in JIRA, ensuring documentation is factual, objective, and compliant with quality requirements.
• Coordinate cross-functional teams, track deliverables, and ensure investigations and projects meet established timelines and budgets.
• Escalate product issues that may violate safety-critical requirements, risk controls, or product labeling claims for field-action review or nonconformance management.
• Collaborate with Systems Engineering, Software, Quality Assurance, Regulatory Affairs, Service, Operations, Marketing, and other stakeholders to resolve product issues.

Required Qualifications:

• Bachelor's degree in Engineering or a related field, or equivalent experience.
• Minimum of 5 years of relevant professional experience.
• Experience in a regulated industry, preferably medical devices, pharmaceuticals, or automotive.
• Experience with product defect investigations, issue triage, root cause analysis, and risk assessment.

Preferred Qualifications:

• Experience with JIRA or similar issue-tracking and backlog management tools.
• Familiarity with product risk management, software requirements, and testing.
• Experience with safety-critical product issues, risk controls, field-action assessments, or nonconformance management.
• Experience working with software and systems engineering teams in a regulated product development environment.

Pay Scale: Anticipated hourly pay range: $55/hr to $58/hr (W2), depending on experience (DOE).

Benefits: Employees hired into this position may be eligible for benefits, subject to applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options may be available through a third-party provider. Employees may be responsible for some or all insurance premiums, depending on the applicable plan.
• Retirement Benefits: A 401(k) retirement savings plan may be available, subject to plan eligibility and terms.
• Paid Time Off (PTO): PTO eligibility and benefits will be communicated during the hiring process and are subject to applicable company policies and state and local laws.