Senior Design Quality Engineer

TransMedics, Inc.; Andover (MA); On-site; USD 93,000 - 133,000; Full time

Benefits offered by this job

Medical benefits

401K Plan

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. designs and manufactures the Organ Care System (OCS) to preserve donor organs outside the body, enabling better transplant outcomes.

The Senior Design Quality Engineer will guide design controls and risk management for complex electromechanical medical devices with embedded software, working across engineering, regulatory, and manufacturing teams. Based in Andover, MA, this role emphasizes software safety, cybersecurity input, and regulatory submissions, while supporting CAPA

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 8+ years experience in medical device or regulated industry.
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971).
• Medical device software development and/or testing experience with 62304 and FDA guidelines.
• Ability to organize and prioritize workflow across multiple projects.
• Excellent organizational and interpersonal skills in cross-functional teams.
• Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility.

Responsibilities

• Ensure design controls process meets regulatory, corporate, and customer QMS requirements
• Collaborate with engineering, manufacturing, project managers, and regulatory teams
• Support new product development and sustaining projects for complex electromechanical systems with software
• Provide quality input to product user needs, requirements, and specifications
• Drive risk management including System FMEAs and verification of effectiveness
• Support design transfer and regulatory submissions

Skills

Design controls

Risk management

Regulatory compliance

Cross-functional collaboration

Project prioritization

Education

Bachelor’s degree in Engineering or related field

Tools

FDA 62304

ISO 13485

Job description

Job Description: TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

The Senior Design Quality Engineer to join our team in Andover, MA. The Senior Design Quality Engineer role plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. Reporting into the Quality Department, the Senior Design Quality Engineer will collaborate with cross-functional teams supporting New Product Development and Sustaining Engineering projects for complex electromechanical medical devices, with a key focus on Software (embedded and standalone). The Senior Design Quality Engineer will provide input to the project teams for project decisions and development activities, ensuring the execution of design control and risk management activities in accordance with internal procedures and applicable standards/regulations.

RESPONSIBILITIES

• Ensure design controls process for the projects meets applicable regulatory, corporate, and customer QMS requirements
• Collaborate with cross-functional teams including engineering, manufacturing, project managers, and regulatory Support new product development and sustaining projects for complex electrical/mechanical systems with software and disposables, with a key focus on Software in a medical device and embedded Software
• Provide quality input to product user needs, requirements, and specifications
• Provide quality input to critical to quality specifications
• Support development of engineering design documentation
• Support design and process verification and validations activities such as protocols, test cases, reports and resolution of issues identified during testing
• Support design reviews and development of the design history file
• Drive overall risk management process, including System Risk Analyses, FMEAs, risk controls and verification of effectiveness
• Provide quality input for Cybersecurity and Software Safety assessments
• Support Design Transfer activities
• Assist in preparation for regulatory submissions and provide support during audits and inspections
• Apply sound, systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Provide quality input and evaluation for Test Method Validations and Software Tool Validations
• Provide support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary
• Drive enhancements and continuous improvements to Standard Operating Procedures (SOPs)
• Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation
• Mentor and provide guidance to junior engineers
• Perform other Quality Systems related duties as required
• Perform other TransMedics tasks and duties as assigned/required.

REQUIREMENTS

• Bachelor’s degree in Engineering or other scientific or related field
• 8+ years experience in medical device or relevant regulated industry
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971)
• Working knowledge of design development and application of risk management
• Medical device software development and/or testing experience with compliance to 62304 and FDA guidelines
• Ability to organize and prioritize workflow across multiple projects
• Excellent organizational and interpersonal skills working in a cross-functional team
• Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $93,300 - $132,900 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.

EQUAL EMPLOYMENT OPPORTUNITY

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

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

EQUAL EMPLOYMENT OPPORTUNITY

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.