Software Engineer 2
MILLENNIUMSOFT
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.
- 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.
- 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.
- 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.
Vacancy posted 1 day ago
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