Job Description:
POSITION SUMMARY
TransMedics is currently seeking a Design Quality Engineer to join our team in Andover, MA. The 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 Design Quality Engineer will collaborate with cross-functional teams supporting New Product Development and Sustaining Engineering projects for complex electromechanical medical devices. The 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
This position is responsible for, but not limited to, the following:
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Ensure design controls process for the projects meets applicable regulatory, corporate, and customer QMS requirements
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Collaborate with cross-functional teams including engineering, manufacturing, project managers, and regulatory
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Support new product development and sustaining projects for complex electrical/mechanical systems with software and disposables
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Provide quality input to product user needs, requirements, and specifications
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Provide quality input to critical to quality specifications
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Support development of engineering design documentation
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Support design and process verification and validations activities such as protocols, test cases, reports and resolution of issues identified during testing
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Support design reviews and development of the design history file
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Drive overall risk management process, including System Risk Analyses, FMEAs, risk controls and verification of effectiveness
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Support Design Transfer activities
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Assist in preparation for regulatory submissions and provide support during audits and inspections
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Apply sound, systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
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Provide support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary
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Support enhancements and continuous improvements to Standard Operating Procedures (SOPs)
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Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation
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Perform other Quality Systems related duties as required
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Perform other TransMedics tasks and duties as assigned/required.
MINIMUM QUALIFICATIONS
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Bachelor’s degree in a technical field
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3-5 years experience in medical device or relevant regulated industry
PREFERRED QUALIFICATIONS
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Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971)
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Working knowledge of design development and application of risk management
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Ability to organize and prioritize workflow across multiple projects
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Excellent organizational and interpersonal skills working in a cross-functional team
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Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility
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System-level design and development experience
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Experience with Electromechanical medical devices
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Prior contribution to quality processes for control of design and development
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CQA certification
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.
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.
