Project Lead /Onsite coordinator (Medical Devices, sustaining engineering, Risk management)
Apply NowLocation:
Raynham, MA, US
Company:
Blackapple Solutions Ltd (BSL) was founded in 2004 with the mission to provide best-in-class IT consultancy services across the globe.
Summary:
The applicant will serve as the Project Lead / Onsite Coordinator for medical devices, overseeing various engineering activities and risk management compliance. Candidates must have a Bachelor's degree in Mechanical or Biomedical Engineering, along with 5-10 years of related experience in the medical devices industry.
Requirements:
Technology: AutoCAD 2012, UG NX6
Hard Skills: Medical Devices Industry Domain, CAD modeling, Risk management, Engineering change requests
Credentials: Bachelor in Mechanical OR Biomedical Engineering
Experience: 5-10 years
Job Description:
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)