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.

Will require onsite presence in Hartland WI few times a month.

WhatYouDo (Responsibilities)

• Lead and manage a team ofsoftware engineersdelivering medical device software solutions.

• OwnAgile delivery execution, including sprint planning,tracking and on-time delivery.

• Driveendtoendsoftware development lifecycle (SDLC)execution in a regulated environment.

• Provide technical leadership acrossdesign, implementation, verification, validation, and sustainment.

• Partner withsoftware architectsto ensure scalable, secure, and clinically safe solutions.

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

• Enforce strongdocumentation, traceability, verification, and audit readinesspractices.

• CollaboratecrossfunctionallywithProduct Management, Quality, Regulatory, Cybersecurity, Manufacturing, Support, and Implementationteams.

• Recruit, mentor, and develop engineers; conduct performance reviews and career coaching.

• Champion responsible use ofGenerative 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.

What You Bring (Qualifications)

• Bachelors degree inComputer Science, Software Engineering, or related field.

• 8+ yearsof software development experience, includingpeople management.

• Proven experience deliveringin a healthcare OR medical device software Or from a regulated environment.

• Stronghandsonunderstanding of:

  • Agile / Scrumdevelopment

  • Regulated SDLC and design controls

  • Risk management and verification & validation (V&V)

• Technical depthto crediblyguide architecture and design discussions.

• Experience leadingcrossfunctionalteams in complex product environments.

• Handsonexperience with Generative AI toolssupporting development workflows (coding, testing, documentation, defect analysis).

Nice to Have

• Experience withclinical systemsand/orcathlab software.

• HL7 integrations, client/server oronpremmedical systems experience.

• Experience supportingFDA submissions, audits, inspections, or field actions.

• Prior leadership inAIassisteddevelopment pipelines.

Why JoinUs

• Build software that directlyimpactspatient care and clinical outcomes.

• Lead ahighvisibility, regulated medical device product.

• Apply modernGenAIenabledengineering practicesin asafetycriticalenvironment.

• Collaborate with passionate and experienced engineers, clinicians, and product leaders.

Compensation

The salary range provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidates experience, qualifications, skills, and the specific requirements of the role. This range may also be subject to change as market conditions evolve. We encourage open communication throughout the interview process to discuss compensation expectations. For base-salary + commission sales roles, the range represents On-Target Earnings.

Min Max :

$155,324.00 - $232,986.00 (USD)

Benefits

The benefits described represent the current offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We strive to provide a comprehensive benefits package that supports our employees health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process.

• 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!