Software Development Manager – Merge Hemo

Merative

Development Manager leading a team for Merge Hemo, an FDA-regulated medical device software platform. Focused on Agile delivery, compliance, and modern development practices.

Posted 5/9/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $155,324 - $232,986 per yearWebsite

Tech Stack

Tools & technologies

Cyber SecuritySDLC

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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)

Benefits

Comp & perks

Remote first / work from home culture
Flexible vacation to help you rest, recharge, and connect with loved ones
Paid leave benefits
Health, dental, and vision insurance
401k retirement savings plan
Infertility benefits
Tuition reimbursement, life insurance, EAP – and more!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

AgileScrumsoftware development lifecycle (SDLC)risk managementverification and validation (V&V)technical leadershipdesign controlsGenerative AIcodingtest generation

Soft Skills

team managementmentoringcross-functional collaborationperformance reviewscareer coachingcommunicationdocumentationaudit readinessproblem-solvingprioritization

Certifications

Bachelor’s degree in Computer ScienceBachelor’s degree in Software Engineering