Manufacturing Engineer- medical devices

Beschreibung

Manufacturing Engineer - Medical devices - 12 months contract

Due to extensive work load related to new medical devices regulation our client , global medical devices company has a contract opportunity for experienced manufacturing engineer to supports manufacturing operations in the areas of process development, tool design, machine programming and equipment.

RESPONSIBILITIES:

• Support the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
  * 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).
  * Assists in gage design, measurement system analysis, and gage implementation as required. * Assists in developing fixtures and designing tools and has the ability to express and implement ideas with tool designers.
  * Assists in the development of manufacturing and inspection procedures.
  * Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
  * Responsible for the creation and release of change orders (COs) through Agile PLM software.
  * 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.
  * Additional duties as assigned.
  PROFESSIONAL EXPERIENCE REQUIREMENTS:
  prior experience in manufacturing or engineering is required.
  Previous experience working in a regulated industry, such as Medical Devices.
  Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
  Demonstrates leadership

Fluency in German and English languages

Michael Bailey International is acting as an Employment Business in relation to this vacancy.