Systems Engineer: Regulated Software Backlog Lead

Rose International; Raleigh (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Rose International seeks a detail-oriented professional to coordinate and manage software backlog for multiple product groups, including NovumIQ, ensuring alignment with program goals.

The role requires strong English communication, organizational skills, and the ability to work independently in a regulated environment. You will collaborate with Systems, Marketing, Sales, Service, and Quality Assurance to define requirements and drive timely resolutions.

Qualifications

• Experience in a regulated industry highly preferred (medical, pharmaceutical, automotive).
• Strong organizational skills.
• Fluent in English (oral and written) with excellent communication skills.
• Works independently, self-motivated with minimal supervision.
• Ability to initiate and develop creative solutions.
• Demonstrates urgency and drive to complete tasks/projects.
• Proficient in Office applications.

Responsibilities

• Coordinate and manage software backlog for one or more groups of related products (e.g. NovumIQ) to achieve defined program goals.
• Develop new products and provide maintenance and engineering support for existing products.
• Interface with Systems, Marketing, Sales, Service, Operations, Medical Affairs, Quality Assurance and Regulatory Affairs to understand requirements and communicate information.
• Lead investigations into observed product defects with subject matter experts.
• Determine cause, impact, and severity of each issue, including affected users and versions.
• Define steps to reproduce issues and identify mitigations.
• Document risk and route any gaps in risk management to the risk owner.
• Coordinate triage of new issue records with clear rationale; ensure unique anomalies proceed to investigation.
• Maintain JIRA issue records as auditable quality records.
• Hold cross-functional peers to deadlines and budgets.
• Escalate safety-critical issues for field-action review or nonconformance management.
• Perform other duties as requested.
• Only those legally authorized to work in the designated country will be considered.
• Note that start dates and durations are estimates and may change based on client needs.

Skills

Fluent in English (oral and written)

Strong organizational skills

Independent / self-motivated

Creative problem solving

Time management & prioritization

Team player with customer service

Proficiency in Office applications

Education

Bachelor's Degree in Engineering or related field and/or equivalent experience

Job description

Rose International seeks a detail-oriented professional to coordinate and manage software backlog for multiple product groups, including NovumIQ, ensuring alignment with program goals.

The role requires strong English communication, organizational skills, and the ability to work independently in a regulated environment. You will collaborate with Systems, Marketing, Sales, Service, and Quality Assurance to define requirements and drive timely resolutions.