Software Engineer 2

3 days ago

San Diego, CA, United States MILLENNIUMSOFT Full time
Roles & Responsibilities

  • Evaluate and remediate gaps in software design control inputs (e.g., system/software requirements) and outputs (e.g., test documentation, software code).
  • Correct traceability errors, document missing traceability, and develop or decompose requirements as needed.
  • Assess existing test cases and determine additional testing needs, conducting back testing if necessary.
  • Maintain thorough documentation of changes and rationales.
  • Gain proficiency in Polarion and assist with data migration and tool population.
  • Modify and implement software design documents using updated templates within the Quality Management System.
  • Collaborate with stakeholders to ensure alignment and address feasibility concerns.
  • Identify and mitigate risks early in the process.
  • Communicate project status, technical concepts, and design details effectively.
  • Identify opportunities for process improvements in software engineering.
Experience Required
  • Minimum of 5 years in software engineering, systems engineering, medical device development, or design control management.
  • Experience with regulatory standards (IEC 62304, FDA guidance, IEEE standards) in a regulated industry preferred.
  • Background in quality engineering or project management is a plus.
  • Proven ability to lead multi-disciplinary engineering teams.
Skills & Certifications
  • Experience in software engineering, requirements management, test documentation, and traceability.
  • Strong understanding of regulatory compliance and risk mitigation (FMEA).
  • Proficiency in documentation, particularly for requirements and specifications.
  • Familiarity with Microsoft Office Suite and digital tools like Teamcenter, Polarion, SAP, DOORS, and ADO.
  • Excellent communication, problem-solving, and leadership skills.
Eligibilities & qualifications
  • Bachelor's degree or higher in a STEM field (postgraduate degree preferred).
  • Certifications in Scrum, Agile, or INCOSE are a plus.
  • Must be legally authorized to work in the U.S. without sponsorship.

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