Job Details

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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 hardware-centric design control elements.
• Drive continuous improvement, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.
• Develop or modify and implement hardware design documentation templates within the Quality Management System that comply with industry standards and regulations, ensuring end-to-end traceability and remediation of gaps and errors.
• Translate business and regulatory requirements into comprehensive hardware development processes; maintain clear communications with stakeholders and management; identify risks and mitigations early.
• Facilitate cross-functional collaboration across departments (Systems Software Test Quality etc) to resolve alignment or feasibility issues; communicate project status and technical concepts effectively to stakeholders.
• Identify opportunities for process improvement within Hardware and Test Engineering to enhance efficiency, quality, clarity, and compliance.
• Serve as a technical resource for addressing process and documentation issues; apply DFSS and Agile mindsets to projects; review and remediate hardware design control documentation.

Minimum Qualifications

• Education: Bachelors degree in Science or Engineering is required; postgraduate degree preferred.
• Experience: Minimum of 5 years of related work in hardware engineering; experience with regulatory standards (IEC 62304, FDA guidance, IEEE) in a regulated environment is highly preferred.
• Leadership: Demonstrated ability to lead multi-disciplinary engineering teams; strong organizational skills; ability to work independently and with teams; ability to manage multiple tasks and priorities.
• Technical Skills: Strong background in hardware engineering, requirements management, and implementation of test processes; hardware product development lifecycle; experience with ALM/PLM and CAD tools is a plus; knowledge of design and development documentation.
• Communication: Exceptional written and verbal communication with the ability to convey technical concepts to stakeholders of varying technical abilities.

Qualifications (Additional)

• Technical methods: DFSS, Agile mindset; experience with hardware design control management is a plus.
• Location & Travel: Remote position; some travel up to 10% may be required to support workshops and intensives.
• Job specifics: Senior - Level; Employment Type: Contract on W2; Duration: 12 Months; Total Hours/Week: 40; Shift: 1st

This is a remote role with potential travel; client: Medical Devices Company.