SOLUTIONS ARCHITECT ENGINEER

Position Overview

 We 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 a 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 Responsibilities

• Design & 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 & Skills

Education:

• 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

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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.

Soft skills:

• 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.

Application Documents:

• Curriculum Vitae (includingyour contact details).
• Motivation Letter

Posting Contact Information

Candidates must submit the documents via email: info@reveal-genomics.com, including the reference code Ref. 12a-2024

General Data Protection Regulation

Pursuant to current legislation on Data Protection, specifically, Regulation (EU) 2016/679 and Organic Law 3/2018 PDGDD, we inform you that the personal data you will voluntarily provide us with through your CV, forms, tests and face-to-face interviews will become part of our information systems, owned by REVEAL GENOMICS, S. L. and will only be processed to manage your application in this selection process or in subsequent processes compatible with your professional profile, processing to which you expressly consent by signing this document.

If you are not a selected candidate, the data provided will be kept for a maximum period of 2years from the end of this selection process. These data will not be passed on or communicated to third parties, except in the case of legal obligation.

You have the right to obtain confirmation as to whether or not we are processing your personal data and you, therefore, have the right to access your personal data, rectify inaccurate data, or request their erasure when the data are no longer necessary, by writing to C.Villarroel, 170 2º 5ª, 08036 Barcelona or via email to: info@reveal-genomics.com  You can contact the competent supervisoryauthority (www.aepd.es) for any complaint you may have.

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