Description
Responsibilities include:- 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.
- 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 manufacturing technologies to strategically develop business objectives and potential opportunities.
- Complying with applicable FDA and international regulatory laws/standards
Qualifications include:
4 to 8 years of relevant experience, preferably in a medical device industrycatheter and stent final assembly experience is a plus!
- Experience with design and process FMECA, Process Validation and variability reduction applications.
- Medical device experience.
- Implementation 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