Demo

Staff Software/Systems Engineer

Cynet Systems
San Diego, CA Full Time
POSTED ON 3/4/2025
AVAILABLE BEFORE 5/25/2025

Job Description :

Pay Range : $59hr - $64hr

Responsibilities :

  • Outputs : Test documentation, software code sections, wireframes, etc.
  • Remediate the identified gaps or errors by either : correcting errors in traceability, documenting traceability where none currently exists, and / or decomposing (or developing) requirements as needed.
  • Evaluate existing test cases and determine any additional testing that is required; if needed, conduct back testing and document accordingly.
  • Ensure thorough documentation of all recommended changes and associated rationales.
  • Develop proficiency in the digital requirements management tool (Polarion) and assist with data migration and population within the tool.
  • Incorporate the remediated content to modify and implement software design documents based on updated templates within the Quality Management System.
  • Work collaboratively across departments to ensure alignment with additional stakeholders, development teams, and business objectives and to address strategic or feasibility concerns.
  • Maintain frequent and clear communication with team members and leaders across the project.
  • Identify risks and issues early on; and implement mitigations as necessary.
  • Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering.
  • Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities.
  • Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance.

Minimum Qualifications :

  • Bachelor's degree or higher in a STEM field is required; postgraduate degree preferred.
  • Scrum, Agile, INCOSE certifications are a plus.
  • Experience :

  • Minimum of 5 years of related work experience in software engineering, systems engineering, medical device development, design control management, and / or similar fields.
  • Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred.
  • Experience in Quality engineering and / or project management is a plus.
  • Leadership :

  • Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader.
  • Positive attitude with an aptitude for critical thinking; comfortable in a fast-paced environment.
  • Eagerness to learn and adapt to new challenges and technologies; robust problem-solving skills.
  • Creative mindset; able to work autonomously and with a group.
  • Strong organizational skills; able to handle multiple tasks simultaneously and prioritize workload.
  • Technical Skills :

  • User needs assessment and interpretation / application of regulations and FDA guidance.
  • Requirements management, test documentation, and end-to-end traceability.
  • Software system analysis and architectural design.
  • Failure Modes Effects Analysis and software impacts to risks and mitigations.
  • Extensive experience in the creation and maintenance of design and development documentation is preferred, especially related to requirements and specifications.
  • Proficiency in Microsoft applications (Excel, Word, PowerPoint, Outlook, Project, Visio).
  • Experience with digitalization tools (Teamcenter, Polarion, SAP, DOORS, ADO, MBSE) is a plus.
  • Communication :

  • Strong interpersonal skills, including : collaboration, problem solving, conflict resolution, peer leadership and motivation, etc.
  • Strong writing abilities and attention to detail are essential.
  • Salary : $59 - $64

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