Sr. Director, Software Engineering (Validation and Verification)

The Sr. Director of Software Development, Validation, and Verification is responsible for leading a global R&D SV&V organization, participating and consulting on activities in all phases of the software development and instrumentation lifecycle, with a focus on verification and validation testing of medical devices and connectivity solutions. This role leverages software testing proficiency to translate product requirements into test strategies and document work to ensure compliance within a regulated Product Development Process. The Sr. Director will ensure compliance with regulatory standards, manage the software development lifecycle, and drive innovation in software solutions.

Key Responsibilities:

• Leadership and Management: Oversee and mentor a team of software developers and engineers, fostering a collaborative and productive work environment.
• Software Development: Direct the design, implementation, and maintenance of software applications, ensuring they meet quality and regulatory standards.
• Validation and Verification: Ensure all software products undergo rigorous validation and verification processes to comply with industry regulations (e.g., FDA, ISO 13485).
• Innovation and Improvement: Identify and implement best practices and new technologies to enhance software development processes and product quality.
• Project Management: Manage software development projects, including planning, execution, and reporting to senior management.
• Stakeholder Collaboration: Work closely with internal and external stakeholders, including regulatory bodies, to ensure successful project outcomes.
• Automated Testing Solutions: Develop automated software testing solutions for medical devices.
• Test Strategy: Create and implement overall software test and automation strategy.
• Test Protocols: Develop automated test protocols for verification of software capabilities as specified in the requirements.
• Requirements Testing: Test the requirements, architecture, and design for medical devices to meet customer needs.
• Collaboration: Collaborate with the software architect and systems engineers to ensure the software architecture meets specifications and is ready for verification and validation, based on hazards and customer needs.
• Documentation: Develop, test, maintain, and document software testing components, applications, scripts, and tools.
• Product Development Participation: Participate in all phases of product development, including reviewing requirements, architecture, design, risk assessment, and testing execution.

Qualifications:

• Education: Bachelor's degree in Computer Science, Engineering, or a related field; advanced degrees (MS, MBA) preferred.
• Experience: 10+ years of software development experience, with at least 5 years in a managerial role within the medical device industry.
• Technical Skills: Proficiency in programming languages (e.g., C++, C#, .NET), experience with software development tools, and familiarity with regulatory standards (e.g., FDA 21 CFR Part 820).
• Soft Skills: Strong leadership, communication, and project management skills.

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