(Contract) Design Quality Engineer

TransMedics Group, Inc.•Andover, MA

29d

About The Position

TransMedics is currently seeking a Contractor to join the Design Quality Engineer team in Andover, MA. The Design Quality Engineer plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. 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.

Requirements

Bachelor's degree in a technical field
3-5 years experience in medical device or relevant regulated industry

Nice To Haves

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
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
System-level design and development experience
Experience with Electromechanical medical devices
Prior contribution to quality processes for control of design and development
CQA certification

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
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
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 support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary
Support enhancements and continuous improvements to Standard Operating Procedures (SOPs)
Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation
Perform other Quality Systems related duties as required
Perform other TransMedics tasks and duties as assigned/required.