Systems Engineer

Stefanini is looking for Systems Engineer in Raleigh, NC (Hybrid) For quick Apply, please reach out to Utkarsh Singh - call: 2482133604 / email: UtkarshKumar.Singh@Stefanini.com Work Hours: M-F (40 hours) Work Location: Raleigh, NC Hybrid (3 days onsite - prefer Tues, Wed, Thurs and 2 remote) Shift: 1st Shift Responsible for coordination and management of software backlog for one or more groups of related products (i.e. NovumIQ) to achieve defined program goals. This includes work related to the development of new products, and maintenance and engineering support of existing products. Interfaces with other departments including Systems, Marketing, Sales, Service, Operations, Medical Affairs, Quality Assurance and Regulatory Affairs to understand product requirements, communicate important information, and address issues relative to each product. Responsibilities: • Drive and own investigations into observed product defects, coordinating with subject matter experts. • Determine the cause, impact, and severity of each issue, including affected users, interfacing systems, frequency, and affected versions. • Define the steps required to reproduce each issue and identify the mitigations already in place. • Document the risk of leaving the issue unresolved and route any gap in the risk management file to the risk owner. • Coordinate triage of new issue records so duplicates are closed with a written rationale, and unique anomalies proceed to investigation. • Facilitate clear, concise, and accurate documentation of the investigation, analysis, and disposition of each issue. • Maintain issue records in JIRA as auditable quality records limited to facts and data, with each field complete or marked not applicable. • Hold cross functional peers accountable to deadlines and timelines to ensure projects are completed within the agreed timeline and budget. • Escalate distributed-product issues that violate a safety-critical requirement, risk control, or label claim for field-action review or nonconformance management. • Performs other duties as requested. Job Requirements Details: Job Requirements: • Bachelor's Degree in Engineering or related field and/or equivalent experience and 5+ years of experience. • Experience in a regulated industry is highly preferred. (medical, pharmaceutical, automotive) • Must have strong organizational skills. • Must be fluent in English (both oral and written) with excellent oral and written communication skills. • Works independently, is self-motivated and able to complete tasks with minimal supervision. • Must have the ability to initiate and develop creative solutions. • Acts with a sense of urgency illustrates ambition and drives for completion of tasks/projects. • Strong proficiency in Office applications skills. • Must be a team player, possess outstanding customer service skills and be self-motivated. • Possess good listening skills and easily learn new skills and concepts. • Ability to manage time and prioritize work. • Must be flexible and adaptable. • Possess the ability to manage time and prioritize critical priorities. • Must demonstrate the ability to increase knowledge. Key Skills: • Clear written and verbal communication. • Multi-disciplinary project experience across areas such as quality, risk, software, requirements and testing. • Strong critical thinking. Physical demands and work environment: • Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. Work environment: The work setting is an office environment which has minimal noise level. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. #LI-US1 #LI-HYBRID Pay Range: $ 80.00 - $ 90.00