Software Engineering Manager-Medical Device #0653

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About this role

We are seeking an experienced and driven Software Engineering Manager to lead the development of innovative software solutions within the medical device space. This role is responsible for managing a team of software engineers, guiding technical strategy, and ensuring the successful delivery of high-quality, compliant, and scalable products that support patient care and safety.

As a key leader, you will collaborate cross-functionally with R&D, Quality, Regulatory, Product Management and Business Development teams to develop software that meets both user needs and stringent industry standards. You will play a critical role in fostering a culture of technical excellence, continuous improvement, and accountability.

What You'll Do

• Provide ECI leadership on client facing engagements and manage client software deliverables (including but not limited to SaMD, SiMD, Digital Health, AI, etc.).
• Lead, manage, and mentor a team of software engineers, fostering a culture of technical excellence, collaboration, and continuous improvement.
• Oversee the entire software development lifecycle, from requirements gathering and design to implementation, testing, deployment, and maintenance, adhering to medical device regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304, Cybersecurity, etc.) and the retrospective remediation of existing software design documentation.
• Collaborate closely with product management, quality assurance, regulatory affairs, and other cross-functional teams to define project scope, technical requirements, and delivery timelines.
• Drive architectural decisions, technology selection, and best practices within the engineering team, ensuring scalability, reliability, and security of software products.
• Manage project priorities, resources, and risks, proactively identifying and mitigating potential roadblocks to successful project completion.
• Champion agile development methodologies (Scrum, Kanban) and continuously optimize team processes for efficiency and effectiveness.
• Participate in strategic planning for software development, contributing to technology roadmaps and long-term vision.
• Recruit, onboard, and retain top engineering talent, fostering a positive and challenging work environment.
• Collaborate with ECI business development team to identify and secure software services contracts/opportunities.  
• Stay current with emerging technologies and industry trends, applying relevant advancements to our product development.
• Participate in speaking engagements regarding ECI’s software capabilities and/or relevant industry topics.

What We Look For

• Bachelor's or master's degree in computer science, Software Engineering, or a related technical field.
• Minimum of 10 years of experience in software development, with at least 3 years in a leadership or management role.
• Proven experience managing medical device software development teams
• Strong technical background with expertise in one or more programming languages (e.g., C#, C++, Java, Python) and software architecture principles.
• Solid understanding of embedded systems, real-time operating systems, and hardware/software integration.
• In depth working experience with medical device software development lifecycle processes and regulatory compliance (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304, Cybersecurity).
• Demonstrated ability to lead and motivate a technical team, fostering a collaborative and high-performance environment.

  •    Excellent communication, interpersonal, and presentation skills, with the ability to effectively communicate complex  technical concepts to diverse audiences. •    Strong problem-solving abilities and a pragmatic approach to technical challenges.

  •    Experience with agile development methodologies and tools (Jira, Confluence, Git).

  •    Work Environment: Remote with travel as needed to client sites, conferences, etc. 25-50% travel  

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.