Hello Business Partner,


Hope you are doing well Today.

Please reply to* [email protected] <[email protected]>*

Find below our requirement. Please respond with Most suitable resume
immediately to the below mentioned ID along with contact information and
rate to carry out further discussions.



*Compliance Engineer*

Location – Braintree, MA

Duration -  6  months



*Job Description *

*Summary:*
This position applies electrical, electronic, and/or mechanical principles
to components and systems, including assembly, analysis, and documentation
of results; construction of developmental or prototype assemblies,
sub-assemblies and components; and quality testing. Participates in the
design, test, modification, fabrication, and assembly of prototype
electromechanical systems. Interprets federal, state, and/or international
regulations as they apply to Clients products, processes, practices, and
procedures. Implements policies and procedures to ensure that these are in
compliance with the appropriate statutes and regulations and that
regulatory reporting requirements are met. Investigates and resolves
technical product compliance problems.
Principal Responsibilities:
• 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 the safety and EMC requirements and test methods for
medical equipment in North America (UL, CSA) Europe (CE, MDD, IEC, EN, VDE)
and Asia (JIST).
• Involvement in the product validation testing and safety agency testing
including Software, Hardware, and Electromagnetic Compatibility.
• Keep abreast of industry trends in product safety and EMC, Train
engineers on updated/new regulations as they become relevant for Clients
devices.
• Participate in Risk Assessment activities including the development of
Hazard Analysis and FMEA’s for safety and compliance related risks and
mitigations.
• Provide guidance in the application of the appropriate national and
international safety requirements.
• Responsibilities include involvement in early stages of new product
development and changes to existing devices.
• Responsible for development and implementation of strategies to secure
and maintain national and international safety and EMC certifications (UL,
cUL, CE in accordance with MDD, JIST, etc.) for all new and existing
Hardware products.
• Specifies or provides assistance in the selection of new and alternate
components.
• Specifies system test apparatus and equipment for pre-compliance
evaluations
• Work with purchasing department and outside vendors on safety standard
requirements of purchased components.





*Candidates Information: *

Full Name :
Location :
Contact Number :
Email :
Availability :
Visa Status :





Thanks & Regards,

*Saif*

Malektron Solutions Inc.

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