Senior Software Development Engineer - Cloud Dev

Job Description:

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships

POSITION SUMMARY

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.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• General Office Environment
• Ability to lift up to 25 lbs.
• May travel up to 10% domestically / 10% internationally

MINIMUM QUALIFICATIONS                                                         

• 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).

PREFERRED QUALIFICATIONS

• 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 experienc