Senior Design Quality Engineer

JOB DESCRIPTION

Position: Sr. Design Quality Engineer

Reports to: Senior Director, Quality Assurance

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