Principal AWS Solution Architect, Technical Lead - Andover, MA

• Join a medical device company truly making a difference
• Excellent base salary & bonus on offer

About Our Client

The company is a commercial-stage publicly traded medical technology company transforming organ transplant therapy for patients worldwide.

Job Description

The successful Hybrid Principal AWS Solution Architect, Technical Lead responsibilities will include but not be limited to:

• Work with clinical leads and other stakeholders to determine customer needs for regulated digital software applications
• Elicitate software requirements to support customer needs
• Develop end-to-end cloud-based solution architecture to monitor and control medical systems
• Perform software safety risk analysis activities
• Participate in cybersecurity assessment and ensure a secure architecture and design
• Contribute to the design, implementation, testing, and documentation of the applications
• Participate in the development of system test plans and procedures
• Technically manage software development projects through full product lifecycle
• Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304
• Manage procedures and deliverables for software verification and regulatory submission
• Address field complaints by determining root cause and implementing corrective actions
• Support quality audits and the development of FDA submissions

The Successful Applicant

The successful Principal AWS Solution Architect, Technical Lead will have the following experience:

• BS/MS in Computer Science, Engineering, or equivalent combination of education and experience.
• 10+ years of related experience in a solutions architecture or equivalent role, with at least 2-3 years focused on developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD).
• Demonstrated experience designing and implementing highly available, scalable, and secure applications on the AWS cloud.
• In-depth, hands-on experience with core AWS services, including but not limited to:
  
  
  Compute: Lambda, EC2
  Databases: DynamoDB, Aurora
  Data Analytics: Kinesis, S3, Redshift
  Security: IAM, KMS, Cognito
  Application Integration: API Gateway, SQS, SNS, Step Functions
• Solid understanding of cloud computing principles, the AWS Well-Architected Framework, and modern architectural patterns (e.g., serverless, microservices).
• Expertise in the regulatory and technical requirements for SaMD development, including quality management systems (ISO 13485) and risk management (ISO 14971).
• Proficiency with infrastructure-as-code (e.g., AWS CloudFormation, Terraform, AWS SAM), CI/CD pipelines, and DevOps best practices.
• Certifications (Preferred): AWS Certified Solutions Architect - Professional AND/OR AWS Certified Security - Specialty
• Extensive experience with the full software development lifecycle in a regulated environment.
• Medical device software development experience with compliance to IEC-62304, IEC-82304, and FDA guidelines is a plus.

• Great communication

What's on Offer

Compensation details for the Principal AWS Solution Architect, Technical Lead include:

• A fantastic base salary depending on experience
• Annual Bonus Target
• Generous PTO
• Hybrid work schedule
• Matching 401k Plan