Overview
On Site
Full Time
Skills
Risk Management
Customer Engagement
Risk Assessment
ISO 9000
Auditing
Regulatory Compliance
ESD
Testing
Job Details
Responsibilities:
Requirements:
- Analyze design documents, specifications, and risk assessments to identify potential safety and performance issues related to device design and functionality.
- Participate in risk management processes, identifying potential hazards, analyzing their severity, and implementing appropriate mitigation strategies.
- Stay updated on regulatory changes and advise cross-functional teams on necessary adjustments to maintain compliance with applicable regulations (FDA, CE Marking, etc).
- Design testing for UL requirements and certifications and CSA/EU 60601 standards certification.
- Hospital BED standards for UL certification and FDA regulations.
- 10DFME, Risk assessment. Single fault analysis.
Requirements:
- BS/MS degree.
- ESD controls, ESD Procedure for ISO audit controls compliance.
- Experience in a NRTL test house would be great.
- Setting up for FCC part 15 testing.
- Setting up and performing ESD testing.
- Setting up for Environmental testing.
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