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