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.
This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
- Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements.
- Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
- Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
- Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
- Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
- Represent the design quality functions for the review and approval of designated design outputs.
- Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
- Support the quality management system as required.
- Perform other TransMedics task and duties as required.
REQUIREMENTS:
- BS in Engineering with 8+ years of related experience or equivalent combination of education and experience.
- Medical device development control experience required.
- Working knowledge of Software development lifecycle desired.
- Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.
- Practical knowledge and experience using Minitab or other statistical analysis tools.
- Understanding and application of Gage R&R and Measurement System Analysis desired
- Process validation experience including IQ/OQ/PQ desired.
- Ability to communicate ideas and information clearly, effectively and concisely.
- Highly detail oriented with strong organization and prioritization skills.
EDUCATION:
- BS in Engineering or other technical discipline
