Beschreibung
For our client in Oberdorf we are looking for a Manufacturing Engineer for a yearly contract.
Duration: till
Location: Oberdorf
Workload: 100%
PROJECT DESCRIPTION:
. 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 including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
. Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
. Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of 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 Activities
. Responsible to originate/oversee/assist in the 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.
. Acts as 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.
. Know and follow all laws and policies that apply to one's job, and maintain the
highest levels of professionalism, ethics and compliance at all times.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
. 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 an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
. Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
OTHER REQUIREMENTS:
. Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
. Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy
. Must be highly organized, creative, articulate and analytical
. Demonstrates strong written, verbal and presentation skills.
. Ability to multi-task independently with minimal supervision
For further details please contact Beata Arciszewska (see below)