Solution Architect, Technical Lead

TransMedics, Inc. • Andover, MA

1d

About The Position

POSITION SUMMARY We are currently seeking a talented and driven Principal Solution Architect, Technical Lead to join our team. Reporting to the Vice President of R&D Software Engineering, the Principal Solution Architect, Technical Lead will have the opportunity to contribute to the life cycle of digital software applications that monitors and controls Organ Care System (OCS™) that preserve donated hearts, lungs, livers, and other organs. TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS™), a first-in-class proprietary device/solution platform, was developed to improve quality, validate viability, and increase the utilization of donor organs for transplantation. TransMedics OCS™ Heart, OCS™ Lung, and OCS™ Liver systems currently have both U.S. PMA approvals and are CE-Marked. TransMedics is the undisputed global leader in organ transplantation in a new multi-billion-dollar medical device industry.

Requirements

• 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).

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
• 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 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.

Responsibilities

• 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
• Perform other TransMedics tasks and duties as assigned/required.

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 251-500 employees