Job Description

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

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# andNET 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 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.

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.

www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $147,200.00 – $183,600.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insurance Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.