Hardware Design Engineer/ Hardware Product Development - Remote

Key Responsibilities

• Develop or modify and implement Electrical, Mechanical, and Test hardware design documentation templates within the Quality Management System that comply with industry standards and regulations.
• Clearly demonstrate end-to-end traceability where hardware design control elements are included, and remediate gaps and errors as needed.
• Translate business and regulatory requirements into comprehensive hardware development processes.
• Work collaboratively to ensure alignment with additional stakeholders, development teams, and business objectives.
• Maintain frequent and clear communication with team members and leaders working in all areas of the project.
• Identify risks and issues early on and implement mitigations as necessary.
• Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering, Software Engineering, Test Engineering, Quality, and others) to resolve alignment or feasibility issues.
• Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities.
• Identify and drive opportunities for process improvement within the Hardware and Test Engineering functions to enhance efficiency, quality, clarity, and compliance.
• Serve as a resource for addressing and resolving issues of process and documentation.
• Apply best practices from methodologies like DFSS (Design for Six Sigma) and an Agile mindset to all projects.
• Review and remediate hardware design control documentation.

Minimum Qualifications

• Bachelor’s degree in Science or Engineering is required; a postgraduate degree is preferred.
• Minimum of 5 years of related work experience in hardware engineering; experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred.
• Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization.
• Positive attitude with an aptitude for critical thinking.
• Willingness to learn and adapt to new challenges.
• Strong organizational skills, ability to work independently and with a group.
• Able to handle multiple tasks simultaneously and prioritize workload.

Technical Skills

• Strong background in hardware engineering, requirements management, and implementation of test processes.
• Experience in hardware product development, including user needs assessment, hardware system analysis and decomposition, architectural design, integration and testing, etc.
• Extensive experience in the creation and maintenance of design and development documentation.
• Experience in Quality engineering and design control management is a plus.
• Experience with ALM/PLM and/or CAD tools is a plus.

Exceptional Communication Skills

• Exceptional communication skills, both interdepartmental and cross-functional.
• Strong writing abilities and attention to detail are essential.