Department: Engineering / Cloud Solutions
Posting Open Date: 2/12/2024
Application Deadline: 31/01/2025
Full Time/Part Time: Full-time
FTE: 1
Hours per week: 40 (Flexible schedule)
Location: Barcelona
Proposed Start Time: Immediate start
About REVEAL GENOMICS, S. L.REVEAL GENOMICS, S.L.
is a cutting-edge MedTech company revolutionizing healthcare through the development of advanced medical devices and solutions towards holistic treatment pathways in oncology for optimal outcomes.
Our innovative products combine the latest advances in machine learning and medical oncology through cloud technology to improve patient outcomes and optimize healthcare workflows.
We are dedicated to maintaining the highest standards in safety, compliance, and quality through adherence to global medical regulatory standards like FDA and CE.
REVEAL GENOMICS, S.L.
is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona (U.B.
), and Vall d'Hebron Institute of Oncology (VHIO).
Position OverviewWe are seeking an experienced Solutions Architect Engineer to lead the design and deployment of cloud-based software as a service solution that is compliant with FDA and CE certifications.
The ideal candidate will have a deep understanding of cloud architecture, machine learning, and regulatory requirements in the medical device industry.
You will join an extremely motivated team committed to performing high impact work in the precision medicine field.
You will collaborate closely with cross-functional teams, including product development, compliance, data science, and IT to design scalable, secure, and compliant cloud solutions that leverage AI/ML technologies to power our medical products.
EU citizens will be requested a registration certificate in Spain.
Non-EU residents must hold a valid residence and work permit.
Additionally, all applicants must possess educational qualifications that are accredited or recognized by the Ministry of Education to ensure compliance with the standard educational requirements for the role.
Key ResponsibilitiesDesign & Architecture: Architect scalable, secure, and cost-efficient cloud infrastructure (AWS, Azure, GCP) tailored for MedTech solutions, ensuring compliance with FDA and CE regulatory requirements.Secure Development & Data Privacy by Design: Integrate security and privacy best practices into the development lifecycle, ensuring all solutions are built to meet stringent MedTech regulatory needs.Machine Learning Integration (MLOps): Collaborate with data science teams to integrate AI/ML models into the cloud infrastructure, optimizing performance, scalability, and regulatory compliance of AI-driven medical applications.Cloud Security: Implement and maintain industry-standard cloud security protocols such as HIPAA, NIST, and HITRUST to safeguard sensitive medical data.Automation & CI/CD Pipelines (DevOps): Lead the automation of deployment, scaling, and management processes by implementing CI/CD pipelines in a regulated environment.Collaboration & Leadership: Work closely with cross-functional teams, including engineering, product management, quality assurance, and regulatory affairs to align technical solutions with business and regulatory goals.Vendor & Partner Management: Manage cloud service providers and third-party partners, ensuring they meet the company's stringent security, performance, and compliance requirements.Documentation & Quality Assurance: Develop and maintain comprehensive technical documentation for cloud deployments, including design specifications, risk management, and validation/verification processes to support regulatory audits and submissions.Innovative Technologies: Stay updated with emerging cloud technologies, AI/ML advancements, and regulatory updates, proactively recommending new tools, frameworks, and best practices.Qualifications & SkillsEducation: Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.Experience: 5+ years of experience in cloud architecture (AWS, Azure, GCP), preferably in MedTech or regulated industries.Strong background in developing solutions with FDA, GDPR, and CE certification compliance.Experience in deploying machine learning models in production environments and integrating them into cloud-based medical products.Hands-on experience with CI/CD pipelines, DevOps, and Infrastructure as Code (Terraform, CloudFormation).Proficiency in security standards like HIPAA, HITRUST, and NIST frameworks for healthcare data protection.Technical skills: Expertise in cloud platforms: AWS, Azure, GCP, with strong understanding of managed services such as Kubernetes, etc.Proficiency in Python, Java, .NET Core, C#, Node.js, or Go for developing and integrating machine learning services.Familiarity with ML frameworks such as TensorFlow, PyTorch, and tools for model deployment.Strong knowledge of cloud security, identity and access management (IAM), encryption, and monitoring solutions.Strong problem-solving skills and ability to translate business requirements into technical solutions.Excellent communication skills to work with both technical and non-technical stakeholders.Leadership skills and the ability to mentor and guide engineering teams.Languages: English and Spanish
Nice to Have:Experience with FDA Precert Program and SaMD (Software as a Medical Device) development processes.Certifications such as AWS Certified Solutions Architect, Azure Solutions Architect Expert, or equivalent.Knowledge of regulatory standards such as ISO 13485, ISO 27001, HIPAA, GDPR, and others is a plus.
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