Senior Compliance Engineer
📋 Role Overview & Responsibilities
IntroductionWe 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 youOpportunity 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.
You will be responsible for10+ 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.
You will bring the followingBachelor's Degree in scientific or engineering field.Knowledge of standards and regulations such as ISO 14971, ISO 13485, IEC 60601, 21 CFR 1040.10, 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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This position is located in Worcester County, MA with potential relocation and sponsorship assistance depending on candidate qualifications.
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