MillenniumSoft Inc
Hardware Engineer/ Reliability Engineer(CAD, IEEE or IEC or FDA Required) - Remo
MillenniumSoft Inc, San Diego, California, United States, 92189
Overview
Hardware Engineer/ Reliability Engineer (CAD, IEEE or IEC or FDA Required) - Remote 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 is a remote position; some travel (~10%) may be required to support workshops and intensives. Position Details
Position: Process Hardware Engineer/ Reliability Engineer - Remote 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 (US Citizens, GC Holders, GC EAD, OPT, EAD or CPT eligible) 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. Ensure end-to-end traceability for hardware design control elements and remediate gaps and errors as needed. Leadership: Translate business and regulatory requirements into comprehensive hardware development processes. Maintain frequent and clear communication with team members and leaders across project areas. Identify risks and issues early and implement mitigations. Cross-Functional Collaboration: Facilitate knowledge sharing across departments (e.g., Systems Engineering, Software Engineering, Test Engineering, Quality) to resolve alignment or feasibility issues. Communicate project status, technical concepts, and design details to stakeholders of varying technical abilities. Continuous Improvement: Identify and drive opportunities for process improvement within Hardware and Test Engineering to enhance efficiency, quality, clarity, and compliance. Technical Expertise: Address and resolve process and documentation issues. Apply best practices from methodologies like DFSS and an Agile mindset. Review and remediate hardware design control documentation. Minimum Qualifications
Education & Experience
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred. Minimum of 5 years of related hardware engineering experience; 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. Positive attitude with strong critical thinking. Willingness to learn and adapt to new challenges. Strong organizational skills; able to work independently and in a team. Ability to handle multiple tasks and priorities. Technical Skills
Strong background in hardware engineering, requirements management, and test process implementation. Experience in hardware product development, including user needs assessment, system analysis and decomposition, architecture design, integration, and testing. Extensive experience in creating and maintaining design and development documentation. Experience with Quality engineering and design control management is a plus. Experience with ALM/PLM and/or CAD tools is a plus. Exceptional communication skills and attention to detail. Legal work authorization in the United States without sponsorship now or in the future (no H-1B sponsorship required).
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Hardware Engineer/ Reliability Engineer (CAD, IEEE or IEC or FDA Required) - Remote 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 is a remote position; some travel (~10%) may be required to support workshops and intensives. Position Details
Position: Process Hardware Engineer/ Reliability Engineer - Remote 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 (US Citizens, GC Holders, GC EAD, OPT, EAD or CPT eligible) 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. Ensure end-to-end traceability for hardware design control elements and remediate gaps and errors as needed. Leadership: Translate business and regulatory requirements into comprehensive hardware development processes. Maintain frequent and clear communication with team members and leaders across project areas. Identify risks and issues early and implement mitigations. Cross-Functional Collaboration: Facilitate knowledge sharing across departments (e.g., Systems Engineering, Software Engineering, Test Engineering, Quality) to resolve alignment or feasibility issues. Communicate project status, technical concepts, and design details to stakeholders of varying technical abilities. Continuous Improvement: Identify and drive opportunities for process improvement within Hardware and Test Engineering to enhance efficiency, quality, clarity, and compliance. Technical Expertise: Address and resolve process and documentation issues. Apply best practices from methodologies like DFSS and an Agile mindset. Review and remediate hardware design control documentation. Minimum Qualifications
Education & Experience
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred. Minimum of 5 years of related hardware engineering experience; 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. Positive attitude with strong critical thinking. Willingness to learn and adapt to new challenges. Strong organizational skills; able to work independently and in a team. Ability to handle multiple tasks and priorities. Technical Skills
Strong background in hardware engineering, requirements management, and test process implementation. Experience in hardware product development, including user needs assessment, system analysis and decomposition, architecture design, integration, and testing. Extensive experience in creating and maintaining design and development documentation. Experience with Quality engineering and design control management is a plus. Experience with ALM/PLM and/or CAD tools is a plus. Exceptional communication skills and attention to detail. Legal work authorization in the United States without sponsorship now or in the future (no H-1B sponsorship required).
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