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

Raynham, MA, us on site Until 8/22/2026 First posted March 21, 2025 Last posted March 21, 2025
Job description

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.

About this role

Summary

Coordinate sustaining engineering, risk management, and vendor activities for medical devices.

Job title

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

Experience level

5-10 years

Industry

medical devices

Location requirements

Onsite in Raynham, MA, no remote work allowed

Salary

Not specified

Management role

No

Skills & keywords

Required skills

coordinateengineering change requestsregulatory supportCAD modelingdrawing updatetest methodprotocol writingvendor coordinationrisk managementDFMEARMPRMRISO 14971PLM

Preferred skills

AutoCAD 2012UG NX6

Specializations

sustaining engineeringrisk managementmedical devicesCAD modelingISO 14971
Locations

Structured locations inferred from the posting.

Raynham, MA, USA

On-site City