Lead and manage a team of software engineers delivering medical device software solutions.
Own Agile delivery execution, including sprint planning, tracking and on-time delivery.
Drive end‑to‑end software development lifecycle (SDLC) execution in a regulated environment.
Provide technical leadership across design, implementation, verification, validation, and sustainment.
Partner with software architects to ensure scalable, secure, and clinically safe solutions.
Ensure compliance with FDA regulations and medical device standards (IEC 62304, ISO 14971, IEC 62366, FDA cybersecurity guidance).
Enforce strong documentation, traceability, verification, and audit readiness practices.
Collaborate cross‑functionally with Product Management, Quality, Regulatory, Cybersecurity, Manufacturing, Support, and Implementation teams.
Recruit, mentor, and develop engineers; conduct performance reviews and career coaching.
Champion responsible use of Generative AI tools (e.g., End-to-end Agentic (Copilot or Claude) pipelines including design, coding, test generation, documentation).
Balance delivery speed, quality, technical debt, and patient safety priorities.

Bachelor’s degree in Computer Science, Software Engineering, or related field
8+ years of software development experience, including people management
Proven experience delivering in a healthcare OR medical device software Or from a regulated environment
Strong hands‑on understanding of: Agile / Scrum development
Regulated SDLC and design controls
Risk management and verification & validation (V&V)
Technical depth to credibly guide architecture and design discussions
Experience leading cross‑functional teams in complex product environments
Hands‑on experience with Generative AI tools supporting development workflows (coding, testing, documentation, defect analysis).

Software Development Manager – Merge Hemo

Key skills