Job Description

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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