Overview
On Site
Full Time
Skills
ISO 9000
Regulatory Compliance
Technical Writing
Educate
Collaboration
Electrical Engineering
Software Engineering
Quality Assurance
Medical Devices
Communication
Job Details
Responsibilities:
- Maintain up-to-date knowledge of medical device regulations (IEC 60601, ISO 14971, UL, TUV, FDA).
- Develop and execute test protocols for electrical, system, and software tests.
- Monitor and assess product compliance with evolving standards.
- Update and maintain technical documentation.
- Provide technical input during design and development.
- Educate and collaborate with team members on regulatory standards.
- BS in Electrical or Software Engineering preferred.
- Minimum 8 years of experience in test engineering or equivalent.
- Deep understanding of medical device standards and regulations.
- Strong verbal and written communication skills.
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