[Hiring] Software Development Manager @Merative

Role Description

Merative is seeking a Development Manager / Engineering Manager to lead software engineering for Merge Hemo, a mission‑critical, FDA‑regulated medical device software platform used in cath labs and hospital environments worldwide. This role combines people leadership, hands‑on technical oversight, Agile delivery, and regulated SDLC execution, with a strong emphasis on modern development practices and Generative AI tooling to improve productivity and quality while maintaining compliance.

What You’ll Do (Responsibilities)

• 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 pipelines including design, coding, test generation, documentation).
• Balance delivery speed, quality, technical debt, and patient safety priorities.

Qualifications

• 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).

Requirements

• Experience with clinical systems and/or cath lab software.
• HL7 integrations, client/server or on‑prem medical systems experience.
• Experience supporting FDA submissions, audits, inspections, or field actions.
• Prior leadership in AI‑assisted development pipelines.

Benefits

• 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!