Program Architect / Technical Lead (Medical Device)

Key Responsibilities:

• Design, implement, and maintain a robust and scalable solution (with Microsoft Azure as preference) for medical device networks and applications that will address business and technical requirements defined for the project
• Drive innovation and evaluate emerging technologies relevant to the medical device industry
• Organize technical teams, distribute work, and monitor progress, quality assurance, and performance in a multidisciplinary team environment.
• Mentor and develop team members' technical skills
• Collaborate with the team to identify and mitigate technical risks and challenges in medical device development
• Collaborate closely with product management, operations, and compliance teams
• Develop and maintain documentation of the system architecture and design supporting formal processes specific to medical devices and related industry standards.
• Implement security best practices and ensure compliance with relevant regulations such as HIPAA, GDPR, and MDR
• Present recommendations to engineering, technical leadership, and possible C-level executives.
• Provide technical pre-sales support concerning client opportunities and initiatives.
• Guide and oversee technical governance, provide design direction, conduct architectural reviews, and make critical design decisions across the product portfolio
• Analyze and shape business and technical requirements, processes, and problems, working with other workstreams to define technical architecture.

Requirements

Qualifications and experience required:

• Minimum 5 years of hands-on experience as a senior technical lead or principal engineering role.
• Strong knowledge of cloud system designs and infrastructure best practices
• Proficiency and experience in .Net development and technologies
• Experience with the design and implementation of databases, API, and backend services
• Experience in CI/CD processes and operations (including Azure DevOps)
• Experience with tools: Sparx Enterprise Architect (or relevant)
• Expertise and practical application of architectural design patterns and guiding principles for cloud system performance, scalability, and security.
• Experience working with medical devices, including knowledge of relevant regulations, standards
• Strong knowledge of containerization technologies such as Docker and Kubernetes
• Understanding of regulatory and quality issues associated with medical device development
• Understanding of security standards in the healthcare industry (including HIPAA and GDPR)
• Excellent technical and business writing skills, with experience in modeling tools (with UML as a preference or adequate standard).
• Strong verbal and PowerPoint communication skills at multiple organization levels, including engineering, technical leadership, and C-level executives.
• Experience with providing pre-sales technical support for client opportunities.
• Experience with Agile development methodologies.
• Knowledge of unit testing methodologies and frameworks
• Sound communication, interpersonal, and team working skills
• Good ability to anticipate issues and formulate remedial actions
• Good command of written and spoken English
• Adaptable to various client company cultures
• Ability to work in a multi-site environment with geographically dispersed technical teams
• University degree (or equivalent) in Computer Science, Engineering, or in a relevant discipline.
• Microsoft Certification (such as Microsoft Certified Professional Developer) and AI platform(s) knowledge a plus

The position is contract and full-time, with the person to be located in the Twin Cities area. It is hybrid working, with 1 or 2 days on-site with the client weekly. The duration is 6 months or longer, with likely extensions.