Software Development Manager – Merge Hemo

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and oversee a team of software engineers in the delivery of medical device software solutions.

• Take ownership of Agile delivery processes, including sprint planning, monitoring, and ensuring on-time delivery.

• Drive the complete software development lifecycle (SDLC) execution in a regulated setting.

• Provide technical leadership across design, implementation, verification, validation, and maintenance phases.

• Collaborate with software architects to guarantee scalable, secure, and clinically safe solutions.

• Ensure adherence to FDA regulations and medical device standards (IEC 62304, ISO 14971, IEC 62366, FDA cybersecurity guidance).

• Implement strong documentation, traceability, verification, and audit readiness practices.

• Work collaboratively with cross-functional teams including Product Management, Quality, Regulatory, Cybersecurity, Manufacturing, Support, and Implementation.

• Recruit, mentor, and develop engineering talent; conduct performance reviews and provide career coaching.

• Advocate for the responsible use of Generative AI tools (e.g., End-to-end Agentic (Copilot or Claude) pipelines covering design, coding, test generation, and documentation).

• Balance priorities of delivery speed, quality, technical debt, and patient safety.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Software Engineering, or a related discipline.

• Over 8 years of software development experience, including managing teams.

• Demonstrated experience in delivering software solutions within the healthcare or medical device sectors, or from a regulated environment.

• Strong practical knowledge of Agile/Scrum development methodologies.

• Familiarity with regulated SDLC and design controls.

• Expertise in risk management and verification & validation (V&V) processes.

• Technical proficiency to effectively guide architecture and design discussions.

• Experience in leading cross-functional teams within complex product environments.

• Practical experience with Generative AI tools that support development workflows (coding, testing, documentation, defect analysis).

🏝️ Benefits

• Remote-first / work-from-home culture.

• Flexible vacation policy to help you rest, recharge, and connect with family and friends.

• Paid leave benefits.

• Health, dental, and vision insurance.

• 401k retirement savings plan.

• Infertility benefits.

• Tuition reimbursement, life insurance, EAP – and more!