This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Software Development Manager – Merge Hemo based in the United States.

This role leads the engineering efforts behind a mission-critical, FDA-regulated medical device software platform used in clinical environments such as cath labs and hospitals worldwide. You will manage a team responsible for delivering reliable, safe, and high-quality healthcare software that directly supports patient care and clinical decision-making. The position blends people leadership, technical direction, and Agile delivery ownership within a highly regulated SDLC environment. You will work closely with architects, product leaders, quality, regulatory, and cybersecurity teams to ensure compliance and innovation coexist effectively. A key part of the role involves driving modern engineering practices, including the responsible use of Generative AI tools to improve development speed and quality. This is a high-impact leadership opportunity where engineering decisions have direct implications for patient outcomes and clinical safety.

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Software Development Manager – Merge Hemo based in the United States.

This role leads the engineering efforts behind a mission-critical, FDA-regulated medical device software platform used in clinical environments such as cath labs and hospitals worldwide. You will manage a team responsible for delivering reliable, safe, and high-quality healthcare software that directly supports patient care and clinical decision-making. The position blends people leadership, technical direction, and Agile delivery ownership within a highly regulated SDLC environment. You will work closely with architects, product leaders, quality, regulatory, and cybersecurity teams to ensure compliance and innovation coexist effectively. A key part of the role involves driving modern engineering practices, including the responsible use of Generative AI tools to improve development speed and quality. This is a high-impact leadership opportunity where engineering decisions have direct implications for patient outcomes and clinical safety.

Accountabilities:

Lead and manage software engineering teams delivering medical device software solutions
Own Agile delivery processes, including sprint planning, execution, and release tracking
Drive end-to-end SDLC execution in a regulated environment with strong design controls
Oversee technical direction across architecture, design, implementation, verification, and validation
Ensure compliance with FDA and medical device standards (IEC 62304, ISO 14971, IEC 62366, cybersecurity guidance)
Enforce documentation, traceability, audit readiness, and quality assurance practices
Partner with cross-functional teams including Product, Quality, Regulatory, Cybersecurity, and Support
Recruit, mentor, and develop engineers through coaching, feedback, and performance management
Champion the responsible adoption of Generative AI tools in engineering workflows
Balance delivery velocity, technical debt, compliance requirements, and patient safety priorities

Requirements:

Bachelor’s degree in Computer Science, Software Engineering, or related field
8+ years of software development experience, including engineering leadership or people management
Experience delivering software in healthcare, medical device, or other regulated environments
Strong understanding of Agile/Scrum methodologies and regulated SDLC practices
Knowledge of design controls, risk management, and verification & validation (V&V) processes
Ability to engage in architecture and technical design discussions with engineering teams
Experience working in cross-functional environments with Product, QA, Regulatory, and Operations
Hands-on experience with Generative AI tools for development workflows (coding, testing, documentation)
Strong leadership, communication, and team development skills
Nice to have: experience with clinical systems, HL7 integrations, FDA submissions, or AI-assisted engineering pipelines

Benefits:

Competitive salary range aligned with experience and market benchmarks
Remote-first work culture with flexible work arrangements
Comprehensive medical, dental, and vision insurance coverage
401(k) retirement savings plan
Flexible vacation policy and paid leave benefits
Infertility and family-building support benefits
Tuition reimbursement and ongoing learning support
Life insurance, employee assistance programs, and additional wellbeing resources
Opportunity to build software that directly impacts patient care and clinical outcomes

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Software Development Manager - Merge Hemo