Description
A global Medical Device Company in Minnesota is seeking a Manufacturing Engineer to join its teeam for a 6 month contract opportunity that is likely to be extended.Responsibilities:
- Develops and maintains the documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).
- Provides engineering support for troubleshooting efforts for any process issues in designated area. Summarize and draw conclusions from test results leading to effective technical resolution of process problems.
- Works with Process Development engineers to ensure design for manufacturing elements are incorporated into PDP activities.
- Identifies, justifies, and implements multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
- Designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
- Identify and recommend manufacturing technologies to strategically develop business objectives and potential opportunities.
- Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
- Other duties as assigned or required
Qualifications
Education: BS or MS degree required (Engineering, Manufacturing, other technical field)
Experience:
- 4 to 8 years of relevant experience, including some in a medical device industry.
- Experience with design and process FMECA, Process Validation and variability reduction applications.
- Experience with medical device based products and processing and technologies.
- Implementation and support of Lean Manufacturing, Demand Flow, Total Quality tools.
- Application of statistical and analytical methods such as SPC, SQC, and DOE.
- Process background (development, capability, optimization, validation) within a regulated industry.
- Development of manufacturing documentation (MP, IP, BOM)
- Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design)
- Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.
- Manufacturing continuous improvement support.
- Test protocol generation, execution, and reporting.
To find out more about Real please visit www.realstaffing.com