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blackapple

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

Raynham, MA, US · On-site · Contract

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About the role

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