Principal AWS Solution Architect, Technical Lead - Andover, MA

This position is for a Principal AWS Solution Architect, Technical Lead to contribute to the life cycle of digital software applications that helps preserve donated hearts, lungs, livers, and other organs!Client DetailsThe company is a commercial-stage publicly traded medical technology company transforming organ transplant therapy for patients worldwide. DescriptionThe 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 applicationsElicitate software requirements to support customer needsDevelop end-to-end cloud-based solution architecture to monitor and control medical systemsPerform software safety risk analysis activitiesParticipate in cybersecurity assessment and ensure a secure architecture and designContribute to the design, implementation, testing, and documentation of the applicationsParticipate in the development of system test plans and procedures Technically manage software development projects through full product lifecycleDevelop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304Manage procedures and deliverables for software verification and regulatory submissionAddress field complaints by determining root cause and implementing corrective actionsSupport quality audits and the development of FDA submissions ProfileThe 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, EC2Databases: DynamoDB, AuroraData Analytics: Kinesis, S3, RedshiftSecurity: IAM, KMS, CognitoApplication Integration: API Gateway, SQS, SNS, Step FunctionsSolid 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 - SpecialtyExtensive 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 communicationJob OfferCompensation details for the Principal AWS Solution Architect, Technical Lead include:A fantastic base salary depending on experienceAnnual Bonus Target Generous PTOHybrid work scheduleMatching 401k PlanDesired Skills and 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- 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.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.