Note: The job is a remote job and is open to candidates in USA. MillenniumSoft Inc is a company specializing in medical devices, and they are seeking a highly skilled Hardware Quality Engineer. The role involves defining and implementing hardware design processes that adhere to regulatory standards, ensuring alignment with business needs, and driving continuous improvement efforts.
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
Skills
- 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 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
- 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
- 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
Benefits
- Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
- Remote position
- Some travel (? 10%) may be required to support workshops and intensives
Company Overview