Lead Software Engineer

Hologic•Newark, DE

6d•$128,200 - $200,500•Remote

About The Position

Hologic is seeking a Lead Software Engineer to help design and develop secure, cloud- and edge-based solutions that power the next generation of AI-enabled medical devices. In this role, you will work at the intersection of cloud platforms, AI integration, and regulated medical device software, contributing to innovative technologies that advance diagnostics and improve patient care. You will collaborate with cross-functional teams across Product Management, DevOps, Product Security, and Software Quality Assurance to build scalable, secure, and compliant solutions that support Hologic’s mission to transform women’s health.

Requirements

Bachelor’s, Master’s, or PhD in Computer Science, Software Engineering, or another STEM-related field.
6–8+ years of experience in software engineering, with a focus on cloud and edge-based systems.
Experience developing software in regulated environments, preferably within medical devices or healthcare technology.
Strong understanding of secure software development practices and regulatory compliance.
Familiarity with Quality Management Systems (QMS) and regulated development processes.
Experience integrating AI capabilities into cloud or edge-based applications.
Proficiency with Agile development methodologies and version control systems.
Experience with major cloud platforms, particularly Microsoft Azure or Google Cloud Platform (GCP).
Strong background in containerization, orchestration, and configuration management.
Expertise in software testing practices, including unit, integration, and system testing.
Experience working on distributed development teams using modern collaboration tools.
Strong troubleshooting, debugging, and problem-solving skills.
Proven ability to lead technical decisions and mentor engineers.
Strong communication skills, able to collaborate with both technical and non-technical stakeholders.
Ability to work effectively in cross-functional and remote teams.
Commitment to quality, compliance, and patient safety.

Responsibilities

Design and develop cloud and edge software solutions that integrate with AI-enabled medical devices.
Contribute to architectural decisions involving cloud platforms, deployment strategies, and system security.
Partner with Product Management, Regulatory, and Design Assurance teams to translate business requirements into technical solutions.
Work closely with DevOps, IT, and Product Security to ensure secure development and deployment pipelines.
Support verification and validation activities alongside Software Quality Assurance engineers.
Review code and technical deliverables to ensure alignment with design standards and quality expectations.
Ensure development processes align with medical device regulations and quality standards, including FDA and ISO 13485.
Promote best practices in secure software development, testing, and documentation.
Foster a culture of continuous improvement, collaboration, and knowledge sharing within the engineering team.