Principal Solution Architect, Technical Lead

Job Description:

POSITION SUMMARY

We are currently seeking a talented and driven Principal Solution Architect, Technical Lead to join our team. 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.

RESPONSIBILITIES

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

• 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.

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.

• 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).

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).

• 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:

• 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.

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

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.

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $172,900.00- $215,700.00, 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 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

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.