Mondo · 2 days ago

Design Quality Engineer

United States

Contract

Remote

Mid Level

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Responsibilities

Work within the Design Traceability Matrix (DTM) to ensure traceability of user needs, design inputs, design outputs, and verification/validation processes.

Support new product development projects by managing risk evaluations and generating design requirements that meet end-user needs and standards requirements.

Evaluate end-user needs and industry standards to generate comprehensive design requirements and engineering targets, including design for manufacturing, assembly, and automation.

Contribute to the success of quality system performance measures by completing tasks on time and maintaining a high level of quality.

Collaborate closely with the product development engineering team on the core product line, ensuring all design traceability and risk management tasks are thoroughly executed.

Develop and validate test methods to ensure compliance with design requirements.

Apply creative problem-solving skills to develop innovative test plans and strategies as needed.

Qualification

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Design Traceability Matrix (DTM)Requirements Traceability Matrix (RTM)AerospacePharmaceuticalMedical DevicesProduct DevelopmentDesign InputsDesign OutputsProduct Realization ProcessTest Method ValidationGRI StandardsSix SigmaTechnical BackgroundStatistical BackgroundPhysical CompositionType Tests

Required

Bachelor’s degree in Engineering or a related technical field.

Experience with Design Traceability Matrix (DTM) or Requirements Traceability Matrix (RTM).

Proven experience in a highly regulated environment such as aerospace, pharmaceutical, or medical devices.

Hands-on experience with at least one full lifecycle of product development.

Strong understanding of design inputs, design outputs, and the product realization process.

Experience in test method validation and familiarity with GRI standards.

Black Belt or Green Belt training in Six Sigma or equivalent.

Strong technical and statistical background with the ability to understand and translate the physical composition of a product into specific type tests.