We have an opportunity for a manufacturing engineer to support manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition for medical devices.
* Leads 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. (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. • Participates in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and other sites. • Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
* Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
* 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
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.