Senior Design Quality Engineer
1 day ago
TransMedics, Inc. is a pioneering company in the field of organ care, revolutionizing the way organs are preserved and transported for transplantation. Our innovative Organ Care System (OCS) is designed to address the limitations of traditional cold storage methods, providing a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport.
Job SummaryWe are seeking a highly skilled Design Quality Engineer to join our team. As a key member of our product development team, you will be responsible for various Design Quality Engineering functions, including risk management, design verification, design validation, design assurance activities, and manufacturing process development support.
Key Responsibilities- Ensure the overall health of the design control process and assure that NPI and sustaining projects meet customer expectations and regulatory requirements.
- Partner with Development and Engineering departments to ensure that design control requirements are met in an effective manner to achieve quality by design.
- Provide input to design and manufacturing engineering project DHF deliverables, including material specifications, drawings, inspection procedures, and manufacturing procedures.
- 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.
- 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.
- 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.
BS in Engineering or other technical discipline.
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