Job Description
Roles and Responsibilities:
• Design and develop analog and digital hardware components for electromechanical medical devices.
• Create schematics, PCB layouts, and hardware architecture in compliance with product requirements.
• Select and qualify components considering performance, reliability, and regulatory constraints.
• Collaborate with mechanical and software teams to ensure seamless system integration.
• Develop and execute hardware verification plans including functional, electrical safety, EMC, and
environmental testing.
• Support design verification and validation activities in alignment with IEC 60601 and ISO 80601
standards.
• Troubleshoot and debug hardware issues during development and testing phases.
• Document test procedures, results, and compliance evidence for regulatory submissions.
• Ensure hardware design complies with - IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), ISO
13485 (Quality Management Systems), FDA 21 CFR Part 8...
• Design and develop analog and digital hardware components for electromechanical medical devices.
• Create schematics, PCB layouts, and hardware architecture in compliance with product requirements.
• Select and qualify components considering performance, reliability, and regulatory constraints.
• Collaborate with mechanical and software teams to ensure seamless system integration.
• Develop and execute hardware verification plans including functional, electrical safety, EMC, and
environmental testing.
• Support design verification and validation activities in alignment with IEC 60601 and ISO 80601
standards.
• Troubleshoot and debug hardware issues during development and testing phases.
• Document test procedures, results, and compliance evidence for regulatory submissions.
• Ensure hardware design complies with - IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), ISO
13485 (Quality Management Systems), FDA 21 CFR Part 8...
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