Randstad Professionals is currently looking for a Manufacturing Engineer (Medical device) who will be assigned an interesting challenge for a major client based in the Basel surroundings.
This contract is a great opportunity to join a major client, global group focusing on the Healthcare / Medical device sector.
The initial assignment will start in January 2020 and will last until December 2020.
Contract details :
Start Date : 06 / 01 / 2020
Requisition End Date : 20 / 12 / 2020
Assignment overview :
By May 2024, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
Liaise with all key stakeholders when formulating and communicating the Project Plans.
Ensure continually deployment of the MDR Plan through consistent excellence in project management.
OVERALL RESPONSIBILITIES :
This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment.
Provides direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.
POSITION DUTIES & RESPONSIBILITIES :
Coordinate and Support new equipment acquisition efforts (URS), machine selection, installation, validation, training, and other related equipment responsibilities.
Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (IQ, OQ, PQ, CSV and Test Method Validation).
Performs gage design, measurement system analysis, and gage implementation as required.
Experience with measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc.
to support engineering testing.
Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
Support the Manufacturing Organization in creation, review and release of MPI & Risk Management tasks
Creation & release of change orders (COs) through Agile PLM software .
Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts.
Subject Matter Expertise in GMP and Process & Machine Capabilities
Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
PROFESSIONAL EXPERIENCE :
4-6 years of experience in manufacturing and / or engineering is required.
Previous experience working in a regulated industry, such as Medical Device is preferred.
Six Sigma or Lean Sigma certification or 4 years of experience preferred.
Experience developing and implementing robust automated manufacturing equipment, preferred.
Experience with packaging, Laser, and CNC processes and equipment, preferred
EDUCATIONAL REQUIREMENTS :
Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
Master of Science Degree from in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
OTHER REQUIREMENTS :
IT knowledge : MS Office, Minitab, and databases.
Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive is needed
Must be highly organized, creative, articulate and analytical
If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email
I am looking forward to receiving your applications