​​


*Job title: Mechanical Engineer with (DHF Remediation, Medical Devices,
R&D)Location: Franklin Lakes, NJ 07417Duration: Full time / Contract*
*Mandatory Domain: Mechanical Engineering & Medical Device.*




*Required Skills:Medical device experience(ISO 13485 / FDA Guidelines) –
MandatoryDHF Remediation experience - MandatoryStrong Product Development ,
R&D background – Mandatory*
Plastic material and mold knowledge
Requirement analysis and DTM ( VOC, ISO requirements map to product
specification)
Design verification experience ( plan, protocol ,report, memos and
technical  rationales writing)

*Job Responsibilities:*
Remediate DHF files of Disposable medical device products (Legacy & New
registrations).
Carryout Engineering change management & Design Control activities of
Medical devices.
Perform Sustaining Engineering of Medical devices & associated Project
management.
Carryout Root cause analysis and work on NC/CAPA resolution of Medical
devices.
Perform Design Verification activities not limited to Tolerance analysis
alone of Medical devices.
Develop understanding , perform functional / system testing  & inspection
of medical devices / device components.
Technical writing not limited to Design Verification plans, protocols and
reports,  Measurement System Analysis, Rationale Memos etc.
Perform CAD modeling and drafting using Solidworks with proper usage of
GD&T.
Support in design and development of Medical devices, predominantly Plastic
products.
Good team player / coordination skills between offshore and onsite
​​

Thanks and Regards
*Ethan Hunt*
*Agile Enterprise Solutions Inc*.
Phone: *630-242-8896 Ext:321* || Fax: 630-206-2397
E: *ethan_h...@aesinc.us.com <ethan_h...@aesinc.us.com>* ||
*http://www.aesinc.us.com
<http://www.aesinc.us.com>*

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