Description
A leading Medical Device company in Minnesota now has a fantastic opportunity for an experienced, tactical, hands on Manufacturing Engineer to contribute to its team. This 6 month contract has the potential to be extended, and can also become a permanent role depending o strength of performance.Responsibilities include:
· Developing and maintaining documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).
· Providing engineering support for troubleshooting efforts for any process issues in designated area. Summarizing and drawing conclusions from test results leading to effective technical resolution of process problems.
· Working with Process Development engineers to ensure design for manufacturing elements are incorporated into PDP activities.
· Identifying, justifying, and implementing multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
· Designing and evaluating new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
· Identifying and recommending manufacturing technologies to strategically develop business objectives and potential opportunities.
· Complying with applicable FDA and international regulatory laws/standards and Code of Conduct.
Candidates must meet the following qualifications:
· 4 to 8 years of relevant experience in the Medical Device Industry
· Stent and catheter final assembly experience
· 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.
· BS or MS degree (Engineering, Manufacturing, or other technical field)
To find out more about Real please visit www.realstaffing.com