Principal Solution Architect, Technical Lead

TransMedics, Inc. • Andover, MA

4d

About The Position

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 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. 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 $151,500.00– $237,100.00, 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

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: Mid Level
• Number of Employees: 251-500 employees