Software Engineer 2

MILLENNIUMSOFT

San Diego, CA

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.

Apply

Vacancy posted 1 day ago

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