Our client in the medical device space isseeking an experienced Enterprise Solutions Software Architect. This role involves leading the architecture, design, and integration of enterprise-level software solutions across the organization, ensuring they meet regulatory standards and the highest quality benchmarks. The successful candidate will be responsible for designing scalable, secure, and efficient software systems that support critical medical device functions and align with the company’s strategic objectives.
Key Responsibilities:
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Architectural Leadership:
- Design and implement enterprise software architecture to support medical device applications, services, and platforms.
- Lead the development of scalable and secure solutions that comply with regulatory standards such as FDA, ISO, and HIPAA.
- Ensure software systems are interoperable with existing medical devices, infrastructure, and third-party integrations.
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Enterprise Solutions Strategy:
- Develop and maintain the architectural roadmap for enterprise software solutions that support product development, clinical operations, and business needs.
- Collaborate with cross-functional teams including product management, engineering, compliance, and IT to align software architecture with business goals.
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Technology Evaluation:
- Evaluate new technologies, platforms, and frameworks to ensure the architecture remains cutting-edge and capable of supporting new features.
- Stay updated with industry trends, ensuring the company leverages best practices for cloud-based solutions, microservices, and AI/ML integration in healthcare.
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Regulatory Compliance and Quality:
- Ensure all enterprise software solutions adhere to regulatory and compliance requirements, including data privacy and security.
- Participate in audits and ensure the documentation and processes align with medical device quality management systems (QMS).
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Collaboration and Mentorship:
- Work closely with software engineering teams to guide the development process, ensuring adherence to architectural standards.
- Mentor junior architects and engineers, fostering a culture of technical excellence.
Required Qualifications:
- Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
- 10+ years of software development experience, with at least 5 years in an architectural role.
- Expertise in enterprise-level architecture, including microservices, cloud solutions, and API integrations.
- Strong experience with regulatory compliance in the medical device or healthcare industry (FDA, HIPAA, ISO standards).
- Hands-on experience with cloud platforms (AWS, Azure, or Google Cloud) and containerization technologies (Docker, Kubernetes).
- Solid understanding of data security, privacy, and encryption methodologies.
- Excellent communication skills and experience collaborating with cross-functional teams.
Preferred Qualifications:
- Familiarity with medical device development processes, including software as a medical device (SaMD).
- Experience with AI/ML solutions and their application in healthcare.
- Proven track record of designing solutions that improve efficiency, reduce costs, and enhance product lifecycle management.
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