Software Development Manager - Merge Hemo

Merative•Wisconsin, WI

3d•Remote

About The Position

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.

Requirements

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).

Nice To Haves

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.

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