The Principal Software Systems Engineer will be responsible for managing and overseeing software design, development and sustaining activities. This role will identify and manage the activities of outside software contractors/consultants.
RESPONSIBILITIES:

• Responsible for managing and overseeing the design and development of new software or extensive software revisions.
• Serve as the top level technical expert by creating high-level architectural specifications and addressing problems of systems integration, compatibility.
• Select and utilize tools and methodologies to ensure that software tests identify defects and comply with quality standards.
• Develop, establish, and maintain software quality assurance methodologies, systems, and practices which meet company, customer, and regulatory requirements.
• Establish, maintain, review and approve documentation associated with planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, V&V test plans/protocols/reports and traceability.
• Design, implement, test, debug, and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes.
• Create test plans, test cases, and automation for new features and enhancements to existing features.
• Evaluate test results against expected results, implement improvements to process and recommend alternative testing as needed.
• Ensure SW/FW V&V complies with company policies, procedures and regulations.
• Responsible for Validation to ensure the software meets user needs.
• Lead debugging efforts, root cause investigations, and issue resolution.
• Assist in workload planning and time estimation.
• Prepare, review, submit, and maintain project/product documentation.

BACKGROUND PROFILE:

• Bachelor's degree in Computer Science, Engineering or related field with seven or more years of experience in software engineering OR Master's degree in Computer Science, Engineering or related field with five or more years of experience in software engineering.
• Experienced working in an Agile software development environment
• Experience working (design, test, etc) within a regulated environment (FDA, MDR, etc)
• Potential for managing and building a SW development group
• Adept at working on cross-functional teams
• Specialist on complex technical and business matters
• Takes a team lead role for the work group
• Reports to Director of R&D