Senior Software Development Engineer - Cloud Dev

TransMedics, Inc.•Andover, MA

1d•Hybrid

About The Position

We are seeking a Senior Software Development Engineer (Cloud Dev). You will have the opportunity to lead brand new development efforts, designing and building apps from the ground up to contribute to the life cycle of digital clinical software applications that monitors and controls Organ Care System (OCS™) that preserve donated hearts, lungs, livers, and other organs. If you’re experienced in designing and implementing complex, user-focused iOS apps, approach problems with creativity, and are motivated to make a difference, then come see what we’re all about. This is a hybrid position located in our Andover, MA headquarters.

Requirements

BS/MS in Computer Science, Engineering, or equivalent combination of education and experience.
8+ years of related experience in back-end software development, with at least 1 year on developing Software as a Medical Device (SaMD).

Nice To Haves

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
Experience with AWS services used to build serverless applications including AWS IoT, Lambda, DynamoDB, API GW
Solid understanding of cloud computing principles, the AWS Well-Architected Framework, and modern architectural patterns (e.g., serverless, microservices).
Knowledge of 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: AWS Certified Solutions Architect – Professional 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.
Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
Must be detail-oriented and highly organized.
Ability to communicate effectively: Verbal and written communication is important for collaborating with colleagues, discussing project requirements, and providing updates.

Responsibilities

Design, build, and deploy secure, compliant, and scalable cloud-native services
Develop and maintain IaC templates to automate the deployment of compliant environments
Design, develop, and maintain scalable high-volume RESTful APIs using C# and .NET Core running in serverless environments
Incorporate security guardrails directly into the infrastructure
Implement end-to-end encryption for ePHI at rest and in transit
Write high-quality, auditable code for serverless, containerized applications using AWS services
Configure granular IAM roles and policies to enforce least-privilege access
Build and maintain CI/CD pipelines with integrated AWS DevSecOps security tools
Enable and centralize audit logs using AWS services
Perform automated security hardening by scanning container images, Lambda layers, and EC2 instances
Implement automated, encrypted backups, disaster recovery, and data retention policies
Design, implement, test, and document the applications per regulatory standards, e.g., FDA guidance, IEC 62304
Participate in safety risk analysis activities
Participate in cybersecurity assessment and ensure a secure architecture and design
Participate in the development of system test plans and procedures
Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304
Address field complaints by determining root cause and implementing corrective actions
Support quality audits and the development of FDA submissions
Perform other TransMedics tasks and duties as assigned/required.