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Design Quality Engineer

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TransMedics, Inc.

Sep 11

  • Job
    Full-time
    Senior Level
  • Andover
  • Quick Apply

AI generated summary

  • You must have a BS in Engineering, 8+ years in medical device development, knowledge of 21 CFR Part 820, ISO 13485, and statistical tools, plus experience in process validation and communication skills.
  • You will ensure design control processes meet customer and regulatory standards, review documentation, manage change notices, and provide expertise on quality engineering and risk management.

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.
  • BS in Engineering or other technical discipline.

Responsibilities

  • 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.

FAQs

What is the main responsibility of the Design Quality Engineer at TransMedics?

The main responsibility is to ensure the health of the design control process, supporting product development by managing risk, design verification, validation, and manufacturing process development.

What educational qualifications are required for this position?

A BS in Engineering or another technical discipline is required, along with 8+ years of related experience or an equivalent combination of education and experience.

Is medical device development control experience necessary for this role?

Yes, medical device development control experience is required for this position.

What regulatory standards should candidates be familiar with?

Candidates should have a working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.

What statistical analysis tools are preferred for this role?

Practical knowledge and experience using Minitab or other statistical analysis tools is preferred.

Are there specific quality management skills that are important for this position?

Yes, the position requires expertise in risk management, test method validation, reliability engineering, and process validation.

Does the Design Quality Engineer need to review design control related Change Notices?

Yes, the Engineer will review and approve design control related Change Notices within the documentation system as applicable.

Is there an emphasis on detail-oriented work in this position?

Yes, the role requires a highly detail-oriented individual with strong organization and prioritization skills.

Will the Design Quality Engineer work in collaboration with other departments?

Yes, the Engineer will partner with Development and Engineering departments to ensure design control requirements are met effectively.

Does TransMedics promote diversity and inclusion in the workplace?

Yes, TransMedics is committed to creating an inclusive environment for all employees and does not discriminate based on various protected characteristics.

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TransMedics, Inc.

Redefining what's possible in organ transplantation

Science & Healthcare
Industry
501-1000
Employees
1998
Founded Year

Mission & Purpose

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, and clinical care. With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.