Principal AWS Solution Architect, Technical Lead - Andover, MA - JN-042026-7005988

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

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

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.