Hardware Process Engineer/ Hardware Design Engineer/ Developer [IEE or IEC required] - Remote

Position

We are seeking a highly skilled, driven, and experienced Staff Process Engineer (Hardware) with expertise in defining and implementing hardware design processes and design control deliverables that adhere to regulatory standards within the medical device industry.

Key Responsibilities

• Hardware Design Documentation Remediation: 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.
• Ledgery: 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.
• Cross-Functional Collaboration: 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.
• Continuous Improvement: Identify and drive opportunities for process improvement within the Hardware and Test Engineering functions to enhance efficiency, quality, clarity, and compliance.
• Technical Expertise: 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

• Education & Experience: 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.

Communication Skills

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