Hardware Engineer/ Reliability Engineer(CAD, reputed company or IEC or FDA Required) - Remote

reputed company Hardware Engineer/ Reliability Engineer (CAD, reputed company or IEC or FDA Required) - Remote We are seeking a highly skilled, driven, and reputed company Staff Process Engineer (Hardware) with expertise in defining and implementing hardware design processes and design control deliverables that adhere to regulatory standards reputed company 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 reputed company: Medical Devices Company Job Category: reputed company Level of Experience: Senior Level Employment Type: Contract on W2 (US reputed company, GC reputed company, GC EAD, OPT, EAD or CPT eligible) Key Responsibilities Hardware Design Documentation Remediation: reputed company or modify and implement Electrical, Mechanical, and Test hardware design documentation templates reputed company the reputed company Management System that reputed company with industry standards and regulations. Ensure end-to-end traceability for hardware design control reputed company and remediate gaps and errors as needed. Leadership: Translate business and regulatory requirements into comprehensive hardware development processes. Maintain frequent and reputed company 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, reputed company) to resolve alignment or feasibility issues. Communicate project status, technical concepts, and design details to stakeholders of varying technical abilities. reputed company Improvement: Identify and reputed company opportunities for process improvement reputed company Hardware and Test Engineering to enhance efficiency, reputed company, reputed company, and compliance. Technical Expertise: Address and resolve process and documentation issues. Apply best practices from methodologies like DFSS and an Agile reputed company. 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 reputed company hardware engineering experience; experience with regulatory standards (e.g., IEC 62304, FDA guidance, reputed company standards) in a regulated industry is highly preferred. Demonstrated ability to reputed company multi-disciplinary engineering teams and serve as a technical leader. reputed company attitude with strong critical thinking. Willingness to learn and adapt to new challenges. Strong organizational skills; reputed company to work independently and in reputed company. 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 reputed company 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. reputed company work authorization in the reputed company without sponsorship now or in the reputed company (no H-1B sponsorship required). #J-18808-Ljbffr Apply To This Job