Systems Engineer

Stefanini Group•Raleigh, NC

1d•Hybrid

About The Position

Stefanini Group is hiring a Systems Engineer in Raleigh, North Carolina. This role is responsible for coordinating and managing the software backlog for one or more groups of related products, such as NovumIQ, to achieve program goals. The work includes developing new products and providing maintenance and engineering support for existing products. The Systems Engineer interfaces with departments including Systems, Marketing, Sales, Service, Operations, Medical Affairs, Quality Assurance, and Regulatory Affairs to understand product requirements, communicate relevant information, and address product-related issues. The position is hybrid, with three days onsite and two days remote; Tuesday, Wednesday, and Thursday are preferred onsite days. The schedule is Monday through Friday, 40 hours per week, on first shift. The role is based in an office environment with minimal noise.

Requirements

Bachelor's degree in Engineering or a related field, and/or equivalent experience.
At least 5 years of experience.
Strong organizational skills.
Fluency in English, both oral and written, with excellent communication skills.
Ability to work independently, self-motivate, and complete tasks with minimal supervision.
Ability to initiate and develop creative solutions.
Sense of urgency, ambition, and drive to complete tasks and projects.
Strong proficiency with Office applications.
Team-oriented approach and outstanding customer service skills.
Good listening skills and ability to learn new skills and concepts easily.
Ability to manage time and prioritize work and critical priorities.
Flexibility and adaptability.
Ability and willingness to increase knowledge.
Clear written and verbal communication.
Strong critical thinking.
Ability to sit for extended periods and use a computer, mouse, keyboard, and monitor; ability to communicate and listen in person and over the phone.

Nice To Haves

Experience in a regulated industry is highly preferred, such as medical, pharmaceutical, or automotive.
Multidisciplinary project experience across areas such as quality, risk, software, requirements, and testing.

Responsibilities

Drive and own investigations into observed product defects, coordinating with subject matter experts.
Determine the cause, impact, and severity of issues, including affected users, interfacing systems, frequency, and affected versions.
Define steps to reproduce issues and identify existing mitigations.
Document the risk of leaving an issue unresolved and route gaps in the risk management file to the risk owner.
Coordinate triage of new issue records, closing duplicates with a written rationale and advancing unique anomalies to investigation.
Facilitate clear, concise, and accurate documentation of each issue's investigation, analysis, and disposition.
Maintain issue records in JIRA as auditable quality records, limited to facts and data, with each field completed or marked not applicable.
Hold cross-functional peers accountable to project deadlines and timelines to ensure completion within agreed timelines and budget.
Escalate distributed-product issues that violate a safety-critical requirement, risk control, or label claim for field-action review or nonconformance management.
Perform other duties as requested.