- Opportunity to work on cutting-edge, class II technology with a frontrunning player in the industry.
- Competitive salary and benefits.
- Internal growth opportunities throughout the engineering department.
- 10+ years of experience with development and compliance testing of Class II/III devices.
- Monitor the status of relevant international standards and provide guidance on present and future regulatory testing requirements.
- Support risk analysis activities, including risk management plans, hazard analysis, FMEA, and risk managements reports.
- Support pre-compliance testing and mitigation of new and modified designs.
- Bachelor's Degree in scientific or engineering field.
- Knowledge of standards and regulations such as ISO 14971, ISO 13485, IEC 60601, 21 CFR , etc.
- Knowledge of technical design and risk management documentation, such as design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports.
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Senior Compliance Engineer - Massachusetts, United States - BioTalent
Description
Introduction
We are supporting a global opto-mechanical based device manufacturer as they expand their medical device team. We are seeking a Senior Compliance Engineer with strong international standards familiarity.
This role will offer you
You will be responsible for
You will bring the following