Position Description:

Responsible for coordination of high-priority projects utilizing industry best practices and innovative project management techniques. Executes released product engineering projects as well as other business critical projects as assigned. Works with FDA QSR (Quality System Regulation), 21 CFR 820 and ISO 13485:2003 EN 14971 and EN 62304 for quality systems. Navigates the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Demonstrates an understanding in Process and design failure mode effective analysis and root cause analysis. Applies skills relevant for value engineering and cost saving projects. Uses DOE (Design of Experiments) with statistical analysis and Design for Manufacturing and assembly (DFMA), to ensure product meets quality requirements. Develops protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Utilizes various CAD Tools to include SolidWorks & Pro-E. Demonstrates skills with six sigma processes by leveraging lean sigma black belt certification. Not eligible for relocation assistance.

Basic Qualifications:

Bachelor’s degree or foreign equivalent in Mechanical, Industrial or Biomedical Engineering or related engineering degree and 5 years of experience in manufacturing engineering OR Master’s degree in Mechanical, Industrial or Biomedical Engineering or related engineering degree and 2 years of experience in manufacturing engineering.

Requires a minimum of 2 years of experience in each of the following: ISO 13485; Good Manufacturing Practices (GMP) and Good Documentation practices (GDP); Process and design failure mode effective analysis and root cause analysis; DOE (Design of Experiments) with statistical analysis, Design for Manufacturing and assembly (DFMA); Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV); CAD Tools SolidWorks or Pro-E/CREO; Value engineering and cost savings projects; Using Lean six sigma Greenbelt (DMAIC) or higher

Relocation assistance is not available for this position.

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