Job Description :
Prefer Mechanical engineer – must have Solidworks experience to support ECO work
Must have experience writing and executing Equipment validation protocols – IQ/OQ
Hands on, willing to do whatever is needed
SUMMARY:
Responsible for the technical issues related to maintaining current RetCam Production line and maintaining regulatory compliance. Team member for project to move RetCam operations to a different facility in Pleasanton December 2017.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
¨ Prepare layout of RetCam facility needs to support move to different facility.
¨ Participant on team to move RetCam facility.
¨ Responsible for preparing or modifying detail and assembly drawings from sketches, drawings or instructions using Solidworks or AutoCad. Verifies dimensions, design layout, and detail.
¨ Maintain Solidworks drawings and assemblies in configuration management tool pdmWorks.
¨ Create, modify and train on manufacturing assembly or test methods and associated forms.
¨ Prepare documents necessary to complete Engineering Change Orders
¨ Support Master Validation Plan for relocation
¨ Work with Quality Engineering to write Validation Protocols – Equipment IQ and OQ
¨ Direct execution and/or execute Validation Protocols and write Reports
¨ Other duties appropriate to position or as assigned by management
¨ Solve mechanical and /or software issues from production floor, working closely with electrical engineering, technicians, assemblers, quality engineering, software engineering and Development Engineering
¨ Work with suppliers and quality engineering on nonconforming material, Analysis of Non-Conforming Material for root cause and corrective actions
¨ Maintain production line with respect to process equipment, and facilities
¨ Maintain preventive maintenance on production equipment, work with Quality Engineering maintaining calibration of equipment
¨ Represent Engineering on Material Review Board
¨ Participate in Change Control Board meetings as requested