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

MillenniumSoft Inc is a company specializing in medical devices, and they are seeking a highly skilled Staff Process Engineer with expertise in hardware design processes. The role involves defining and implementing hardware design control deliverables that adhere to regulatory standards, collaborating across teams, and driving continuous improvement efforts.

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
• Leadership: 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

Requirements:

• Bachelor's degree in Science or Engineering
• Minimum of 5 years of related work experience in hardware engineering
• Demonstrated ability to lead multi-disciplinary engineering teams
• 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
• Ability to handle multiple tasks simultaneously and prioritize workload
• 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
• Exceptional communication skills, both interdepartmental and cross-functional
• Strong writing abilities and attention to detail are essential
• The candidate must be legally authorized to work in the United States without limitations and require no sponsorship for visa status now or in the future
• Postgraduate degree
• Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry
• Experience in Quality engineering and design control management
• Experience with ALM/PLM and/or CAD tools