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

blackapple; Raynham (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading IT consultancy firm is seeking a Project Lead/Onsite Coordinator for its medical devices projects in Raynham, Massachusetts. This role requires 5-10 years of experience, particularly in sustaining engineering and risk management. Candidates must hold a Bachelor's degree in Mechanical or Biomedical Engineering and ideally possess knowledge of CAD software like AutoCAD 2012 and UG NX6. You will coordinate with offshore teams and liaise with clients, ensuring compliance with industry standards.

Qualifications

• 5-10 years of experience in a relevant role.
• Bachelor's degree in Mechanical or Biomedical Engineering required.

Responsibilities

• Coordinate with offshore team for sustaining engineering activities.
• Update risk management files for compliance with ISO 14971 standards.
• Liaise between client and internal teams for business activities.

Skills

Coordination with offshore teams

Risk management

CAD modeling

Education

Bachelor in Mechanical or Biomedical Engineering

Tools

AutoCAD 2012

UG NX6

Job description

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

• Contract

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)

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.

Number of interview rounds: 2 rounds (one telephonic, one Telephonic/Skype).

Mandatory Domain: Medical Devices Industry Domain.

Responsibilities

• Coordinate with Offshore team for sustaining engineering activities like:
  • product information support for regulatory
  • CAD modeling
  • Drawing update / creation
  • Test method and protocol writing
• Work on Risk management files updates for DFMEA, RMP and RMR to comply with ISO 14971 2012 standards
• Meet with cross functional team members to review and finalize the risk management files and release them in PLM.
• Function as a liaison between HCL and Client for all base business activities.
• CAD software’s: AutoCAD 2012, UG NX6. (Preferred)

Qualifications

• Experience Level: 5-10 years
• Educational qualification: Bachelor in Mechanical OR Biomedical Engg.

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

Job Location