Hardware Lead
16 hours ago
Job Description
1. Develop PCB architecture and multi-layer board designs for analog, digital, and mixed-signal circuits to design the test fixtures.
Perform risk analysis and mitigation strategies in line with ISO 14971 and other applicable regulatory standards.
Collaborate closely with systems, firmware, mechanical, and software engineers to ensure seamless integration.
Generate and maintain design documentation, including hardware design specifications, test protocols, and reports.
Evaluate design for manufacturability (DFM) and support the transition from design to production.
Specific Job Skills Required
Proven expertise in schematic capture, PCB layout, and use Altium Designer.
Strong understanding of electrical safety, EMC/EMI compliance, and regulatory design constraints
Experience with hardware verification, test fixture development, and failure mode analysis (FMEA).
Ability to work in a cross-functional team in an FDA-regulated environment.
General Skill Required
1. Clear and concise written and verbal communication.
2. Lead the hardware engineering team, managing resources, assigning
tasks, and guiding technical direction.
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