Hardware Design Engineer/ Hardware Product Development - Remote

MillenniumSoft Inc; San Diego (CA); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a highly skilled Hardware Design Engineer to drive innovation in medical device development. This role offers a unique opportunity to shape hardware design processes, ensuring compliance with regulatory standards while collaborating with multi-disciplinary teams. As a key contributor, you will lead efforts to enhance efficiency and quality, addressing complex challenges in the hardware engineering domain. If you have a strong technical background and a passion for continuous improvement, this position is perfect for you to make a significant impact in a dynamic and rewarding environment.

Qualifications

• 5+ years of experience in hardware engineering, especially in regulated industries.
• Bachelor's degree in Science or Engineering required; postgraduate preferred.

Responsibilities

• Develop and implement hardware design documentation templates complying with regulations.
• Lead cross-functional teams to align business and regulatory requirements.

Skills

Hardware Engineering

Requirements Management

Test Processes Implementation

Design Control Management

Communication Skills

Critical Thinking

Organizational Skills

Education

Bachelor's degree in Science or Engineering

Postgraduate degree

Tools

ALM/PLM tools

CAD tools

Job description

Position: Hardware Design Engineer/ Hardware Product Development

Location: San Diego, CA

Duration: 12 Months

Total Hours/week: 40.00

1st Shift

Client: Medical Devices Company

Job Category: Professional

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 & 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.
• 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.
• 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 (e.g. H1-B status).