About ClariMed :
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.
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.
Visit us at www.Clarimed.com.
At Clarimed
- We believe in excellence accelerated.
- We believe in caring and kindness.
- 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).
As a player-coach, you will contribute directly to coding, architecture, and technical mentorship while ensuring best practices in software design, performance, and regulatory compliance. This role requires a deep understanding of Azure Cloud, C# / .NET, Python, AI / ML principles, React, JavaScript, and unit testing frameworks.
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).Full-Stack & Cloud Development :
Develop secure and high-performance applications using C#, .NET, Python, and React / JavaScript.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.Mobile & Cross-Platform Development :
Design, develop, and maintain high-quality mobile applications for iOS and Android.Utilize Swift, Kotlin, JavaScript, Dart, React Native, or Flutter for cross-platform development.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).Hands-on experience with C#, .NET, Python, React, JavaScript, and cloud platforms (Azure preferred, AWS / GCP a plus).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.
