Perform process development and design for manufacturability activities specific to Intramedullary Nails, External Fixation devices and Knee instruments. Develop core mechanical technologies to support manufacturing processes which comply with FDA regulations. Specific duties include: Develop procedures and processes that lead to reliable manufacturing process; Use the philosophy and tools of total quality, lean manufacturing, and design for manufacturability and serve as an engineering resource in teaching the use of these tools to others within the department; Apply knowledge of ISO 9001 and 13485 to manufacturing processes; Develop core technologies required to sustain or improve competitive advantage; Design, develop, analyze and document production processes
which meet the functional, cost, reliability, manufacturability and safety requirements of the customer; Apply skills necessary to design develop and introduce new products with the greatest possible margins and in the shortest amount of time; Identify and implement tools, methods, processes and equipment, which improve the quality, reliability and productivity of the department; Use industry standard CAD systems for design (SolidWorks, Master Cam, Auto Cad) and ISO documentation; Design fixtures and gages and generating 2D prints for manufacturing; Understand all GD&T requirements; Prepare and review pFMEA and control plans and related documents; Manage project launch timelines and hold conference calls with customer sharing information.
5 years of experience in process development and design for manufacturability activities specific to Intramedullary Nails, External Fixation devices and Knee instruments.
Prior experience to include knowledge of:
•programming multi-axis mills, turning centers and Swiss machines utilizing Mastercam and PartMaker software.
•designing fixtures and components utilizing Solidworks, AutoCAD and Pro-E software, which meet the functional, cost, reliability, manufacturability and safety requirements.
•performing product realization activities and document all aspects of production processes including work instructions, tooling information, inspection criteria, pFMEA and control plans.
•quality system and regulatory requirements including FDA, ISO and GMPs.
Job Number: 7149805
Internal Job Number: Not Given
Date Posted/Updated: 10/04/2017
Start Date: 10/04/2017
Job Title: Development Engineer
Job Location: Colorado Springs
Wage: 45,000.00 – 60,000.00 per year
Job Experience: 5 years
Job Type: Regular
Hours Per Week: 40
Job Classification: Full Time
Close Date: 12/31/2017
OJT Interest: Not stated
Minimum Age: Not stated
Driver’s License: None
Background Check: No
Education: Bachelor’s Degree
Drug Test: Yes
Paid Holidays/Year: 7
Health Insurance Available: Yes
Paid Vacation Days/Year: 5
Incentive/Profit Sharing: Yes
Paid Sick Days/Year: 2
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