Software Engineer 2

We are seeking a skilled and experienced Staff Software/Systems Engineer with expertise in developing software design control deliverables that comply with FDA guidance and regulatory standards in the medical device industry. This is a documentation-focused role centered on design controls rather than software development. The candidate will be responsible for remediating software design control items, ensuring accuracy, completeness, and traceability between inputs and outputs.

• 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 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.

• 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.

• 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.