Technical Lead
Technical Lead
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Salary Not Disclosed
1 Vacancy
Job Description
Job Location: Danbury CT
Shift/Schedule: Hybrid / Expected 3 days a week on site
Job Summary:
- We are seeking a highly skilled and experienced Technical Lead to oversee the technical execution of regulated digital health platform initiatives. The role requires deep expertise in architecting and delivering GxP/SaMD-compliant solutions hands-on experience with modern technology stacks and the ability to coordinate effectively with client technical teams and stakeholders.
- The Technical Lead will serve as the technical owner of the solution responsible for ensuring architectural integrity development quality and alignment with compliance and business requirements.
Technical Ownership
- Lead the technical execution of the platform ensuring alignment with architectural standards compliance requirements and delivery milestones.
- Own solution design decisions and guide development teams through implementation testing and deployment.
- Architecture and Development
- Architect scalable secure and compliant solutions using modern technologies including:
- Java Spring Boot Kotlin Microservices
- React JS for front-end development
- AI model hosting and hybrid AI architecture for intelligent features
- Ensure adherence to GxP SaMD GDPR and other regulatory standards throughout the development lifecycle.
- Operate within Agile Scrum methodology supporting sprint planning backlog grooming and technical ceremonies.
- Collaborate with Product Owners and Scrum Masters to ensure technical feasibility and timely delivery.
- Interface with client technical teams to understand integration points infrastructure constraints and compliance expectations.
- Translate business and functional requirements into technical specifications and actionable development plans.
- Oversee code quality testing strategy and documentation to support validation and audit readiness.
- Ensure traceability and alignment with regulatory documentation standards.
- Proven experience in architecting and delivering GxP/SaMD-compliant platforms for Pharma MedTech or Life Sciences clients.
- Strong hands-on expertise in:
- Java Spring Boot Kotlin Microservices
- React JS and modern front-end frameworks
- AI model deployment and hybrid AI architectures
- Deep understanding of Agile Scrum delivery practices.
- Familiarity with regulatory frameworks including GxP GDPR HIPAA ISO 13485 and 21 CFR Part 1
- Excellent communication and stakeholder management skills with the ability to bridge technical and business perspectives.
Employment Type
Full-time
