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Posted 137 months ago

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Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

Raynham, MA, United StatesRemoteContract

AI Summary

Project Lead / Onsite coordinator for medical devices sustaining engineering. Coordinates offshore engineering activities, updates risk management files per ISO 14971, and liaises with the client and HCL.

About this role

Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

Blackapple Solutions Ltd (BSL) was founded in 2004 with the mission to provide best-in-class IT consultancy services across the globe. We are a specialist IT consultancy offering services through our consultants/experts on a contingency basis in the UK, Europe, USA and Asia Pacific. We work with a portfolio of high profile multinational clients across all sectors.


 Role: Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)

 Duration: 6-12 Months plus

 Work location: Raynham, MA 02767

 No of open positions: 1

 Hiring Mode (TP /FTE): TP

Visa: Any

 Experience Level: 5-10 years

 Educational qualification: Bachelor in Mechanical OR Biomedical Engg.

 How many level of internal interview (TP1/TP2/Both): 2 rounds (one telephonic, one Telephonic /Skype).

 Mandatory Domain (Put “NO” if domain is not must.): Medical Devices Industry Domain.

 Required Skills and experience:

 1) Coordinate with Offshore team for sustaining engineering activities like:

 - Engineering change requests

 - product information support for regulatory

 - CAD modeling

 - Drawing update / creation

 - Test method and protocol writing

 - Vendor coordination for prototyping / testing

 2) Work on Risk management files updates for DFMEA, RMP and RMR to comply with ISO 14971 2012 standards

 3) Meet with cross functional team members to review and finalize the risk management files and release them in PLM.

 4) Function as a liaison between HCL and Client for all base business activities.

 5) CAD software’s: AutoCAD 2012, UG NX6. (Preferred)



Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills

AutoCADCAD ModelingDFMEAISO 14971Medical Devices DomainRisk ManagementSustaining EngineeringUG NX

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