Mechanical Engineer
QiG Group, LLC - Blaine, MN

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Mechanical Engineer: Research, develop, characterize, and qualify (IQ/OQ/PQ) new manufacturing processes for Class III implantable devices. Conduct tolerance stack up analysis, finite modeling analysis (thermal and mechanical), propose product/component design changes to assure a robust manufacturing process and reliable product. Design and develop tools and fixtures, while assuring high process capability, biocompatibility and complying with ISO 13485, GMP, FDA regulations and clean room manufacturing practices. Create detailed mechanical engineering designs, update drawings, BOMs, and maintain revision history. Develop process flow diagrams, conduct PFMEAs, design reviews and process validation protocols. Apply six sigma methodologies like process capability (Cpk/Ppk), MSAs, ANOVA, Gage R&R, DOE, hypothesis testing, root cause analysis and regression analysis to achieve long term reliability. Program metrology/process equipment, write process specifications and train technicians.

Special Requirements: Must have prior experience in design and development work, including the use of finite modeling analysis; Class III medical devices and their component development/manufacturing; process development experience with IQ/OQ/PQ for equipment/processes, including laser welding, laser marking, laser cutting, plasma cleaning, and epoxy cure processes; Product knowledge and design/specification development of implantable filtered FTs, stamped cans, and implantable power sources; Extensive experience with various CAD/FEA packages (Solidworks, Pro/E, and AutoCAD), Minitab, GDT, tool and mechanical design and knowledge about various fabrication methods, including stamping, machining, rapid prototyping, molding, and anodizing; Knowledge of various metrology, surface analysis methods, and experience with smartscope, XRF, Gonimeter, and laser profilometer; Knowledge of various biocompatible materials and their mechanical, thermal and electrical properties. Experience with ISO 13485, clean room manufacturing practices, QSR, GMP and lean.

Minimum education and experience requirements: Master’s Degree or the foreign academic equivalent in Engineering or Plastics Engineering, or related, plus 1 year of experience in the job offered or in a related occupation OR Bachelor’s Degree or the foreign academic equivalent in Engineering or Plastics Engineering, or related, and 5 years of progressive experience in the job offered or a related occupation.

Mail resume to: QiG Group, LLC, Attn: Cathy Rojek, Director, Human Resources, 10000 Wehrle Drive, Clarence, NY 14031. EOE.

Greatbatch - 14 months ago - save job - block
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