Lead Software Engineer

ClariMed, Inc.; Boston; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Lead Software Engineer to spearhead innovative solutions in medical technology. This role involves designing and developing secure, compliant software for medical devices, ensuring adherence to stringent FDA regulations. As a hands-on technical leader, you will guide cross-functional teams in implementing cloud-native architectures and integrating cutting-edge AI/ML features. Join a forward-thinking company that values creativity and collaboration, where you can make a real impact on healthcare technology and enhance product quality while enjoying a supportive and empowering work environment.

Benefits

Competitive salary

Growth opportunities

Innovation-driven environment

Real-world healthcare impact

Qualifications

• 5+ years in software development, with leadership in regulated industries.
• Deep understanding of FDA regulations and cybersecurity best practices.

Responsibilities

• Design and develop secure software solutions for medical devices.
• Implement cloud-native architecture and manage Azure Cloud applications.
• Ensure compliance with FDA and IEC 62304 regulations.

Skills

Software Development

Cloud Computing

Cybersecurity

System Architecture

Leadership

Unit Testing

DevOps

Microservices Architecture

RESTful APIs

AI/ML Integration

Education

Bachelor's Degree in Computer Science

Master's Degree in Software Engineering

Tools

Docker

Kubernetes

Azure Cloud

Job description

ClariMed is a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical products.

ClariMed is proud to be Great Place To Work Certified, with an exceptional 98% of employees reporting that people genuinely care about each other here. This certification validates that our human-centered approach extends beyond our client services to our own workplace culture. Our team members thrive in an environment where 95% feel welcomed, empowered with significant responsibility, and are willing to go the extra mile to achieve excellence.

Operating out of Chadds Ford, PA with offices in San Jose, Boston, and Cambridge, UK, ClariMed is building a global, boutique professional services practice that provides human centered design, development and regulatory services to medical device and pharmaceutical manufacturers. With a grounding in quality by design, creativity and risk mitigation from concept inception through pilot lot delivery, we intend to reduce time to market, enhance product quality and convey a compelling risk/benefit positioning for our clients. We will achieve this by intentionally coupling the flexibility of a boutique offering with the breadth of services of a global business, while avoiding the conflicts that come with manufacturing and clinical operations.

• We believe in creating solutions through thinking without boundaries.
• We believe that everyone has a voice and we accept, embrace, and celebrate everyone for all of who they are and provide them with an environment to become who they are meant to be.
• We believe in setting and receiving expectations to ensure that there is clarity and purpose in our actions.
• We believe everyone has something to learn and something to teach - we are life-long learners and educators.

Overview:

We are looking for a Lead Software Engineer with expertise in full-stack web, cloud, and mobile/desktop application development. The ideal candidate is a hands-on technical leader with experience in system-level design, cloud computing, and cybersecurity, particularly within FDA-regulated medical device software (IEC 62304, cybersecurity compliance).

Key Responsibilities:

System Architecture & Technical Leadership:

• Design, develop, and optimize scalable, secure, and compliant software solutions for medical devices and connected health applications.
• Ensure adherence to IEC 62304, FDA, and cybersecurity regulations, addressing threat modeling, secure coding practices, and risk management.
• Work with cross-functional teams to architect cloud solutions, ensuring performance, scalability, security, and compliance.
• Implement cloud-native architecture, microservices, and containerization (Docker, Kubernetes).
• Deploy and manage Azure Cloud applications, ensuring reliability and efficiency.
• Implement DevOps practices, cloud storage solutions, and infrastructure automation.
• Build and maintain RESTful APIs for seamless backend-to-frontend integration.
• Develop AI/ML-powered features for intelligent automation and decision-making.
• Design, develop, and maintain high-quality mobile applications for iOS and Android.
• Collaborate with UI/UX designers to ensure intuitive and visually appealing user interfaces.
• Integrate mobile apps with cloud services and APIs, ensuring seamless data flow.

Cybersecurity & Compliance

• Ensure secure software development practices in compliance with FDA, IEC 62304, and ISO 27001.
• Implement identity management, authentication, and data encryption strategies.
• Conduct threat modeling, vulnerability assessments, and penetration testing.
• Address cybersecurity challenges in connected medical devices and healthcare IoT.

Unit Testing, Quality Assurance & Documentation

• Implement automated testing frameworks for backend, frontend, and cloud-based applications.
• Perform unit testing, debugging, and troubleshooting to ensure software quality and regulatory compliance.
• Write clear and comprehensive documentation for system designs, APIs, and regulatory submissions.

Qualifications & Skills:

Required:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or related field.
• 5+ years of software development experience, with leadership experience in regulated industries (medical devices preferred).
• Deep understanding of IEC 62304, FDA software regulations, and cybersecurity best practices.
• Experience in unit testing, DevOps, CI/CD pipelines, and cloud security.
• Strong knowledge of microservices architecture, RESTful APIs, and database management (SQL/NoSQL).

Preferred:

• Cloud certifications (e.g., AWS Certified Developer, Azure Developer, Google Cloud Professional Cloud Developer).
• Experience in AI/ML model integration within cloud and medical applications.
• Familiarity with containerization (Docker/Kubernetes) and serverless computing.
• Experience working with IoMT (Internet of Medical Things) and connected health applications.

Why Join Us?

• Work on cutting-edge medical technology with real-world healthcare impact.
• Lead a high-performing team with strong technical leadership and autonomy.
• Competitive salary, growth opportunities, and an innovation-driven environment.
• Opportunity to shape cybersecurity, AI, and cloud technology in digital health.