We’re seeking a senior compliance engineer for a growing medical device company in downtown Boston. 

In this position you will be a critical part of our compliance and EMC team and be responsible for all EMC company wide.

This is a great opportunity to have a positive impact on our devises which both save and improve patients lives.

 

We’re looking for:

-Implements policies and procedures to ensure in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met.

-Additionally support of all technical files, communication with safety agencies, monitoring and influencing the processes of creation of new national and international standards and requirements.

-Expert knowledge of EMC and safety requirements and test methods for medical equipment in North America, Europe  and Asia (JIST).

-Involvement in the product validation testing and safety agency testing including Software, Hardware, and Electromagnetic Compatibility.

-Participate in Risk Assessment activities including the development of Hazard Analysis and FMEA’s for safety and compliance related risks and mitigation.

-Specifies system test apparatus and equipment for pre-compliance evaluations 

This position will be working for a Medical Device company with around 1 Billion in Revenue.  Our compensation, benefits and bonus is highly competitive. 

Please apply below to hear more.

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