Hardware Quality Engineer - Remote

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We are seeking a highly skilled, driven, and experienced Hardware Quality Engineer to define and implement hardware design processes and design control deliverables that comply with regulatory standards in the medical device industry. This role requires a strong technical background in Electrical, Mechanical, or Test/Reliability Engineering, leadership capabilities, and extensive experience in product design and development. Experience in Quality and/or Systems Engineering is a plus.

Key Responsibilities

• Shape the process for defining and documenting hardware-centric design control elements and deliverables, ensuring alignment with regulatory requirements (e.g., FDA guidance) and meeting user and business needs.
• Remediate design control documentation for accuracy, completeness, and clear upstream and downstream traceability from hard...