Hardware Quality Engineer
Company: millenniumsoft
Location: San Diego
Posted on: April 1, 2026
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Job Description:
Position : Hardware Quality Engineer Location : San Diego, CA
Duration : 12 Months Total Hours/week : 40.00 1 st Shift Client :
Medical Devices Company Job Category : Engineering Level of
Experience : Senior - Level Employment Type : Contract on W2 (Need
US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Job
Description: 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. 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 also a plus. The engineer will play a
critical role in shaping the process for defining and documenting
hardware-centric design control elements and deliverables, ensuring
alignment with regulatory requirements such as FDA guidance, and
meeting both user and business needs. They will also be remediating
the design control documentation for accuracy, completeness, and
clear upstream and downstream traceability from hardware-centric
design control elements. The ideal candidate will drive continuous
improvement efforts, collaborate across multi-disciplinary teams,
and provide technical expertise to ensure successful project
outcomes. 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. 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. Minimum Qualifications •
Education Bachelor’s degree in Science or Engineering is required;
a postgraduate degree is preferred. Experience 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 Leadership
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 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
Exceptional communication skills, both interdepartmental and
cross-functional Strong writing abilities and attention to detail
are essential This is a Remote position, but some travel (? 10%)
may be required to support workshops and intensives.
Keywords: millenniumsoft, Huntington Beach , Hardware Quality Engineer, Engineering , San Diego, California
