| Develop, release, and execute IQ/OQ Protocols for Fixtures and Tools.
Update and releases improvements/corrections to the quality management system documents for the validation of the manufacturing processes.
Design, procure and implement simple manufacturing aids and transport tooling.
Procure, Assemble Fixtures and Tools
Update documentation (CAD) for Fixtures and Tools and release in our PLM system.
Responsible for maintaining compliance with medical device quality system requirements including corrective action closure, discrepant material dispositions and ECO implementation.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
Skill/Job Requirements:
4 yr. degree in Mechanical Engineering or equivalent
Demonstrated Electromechanical and/or Process Engineering capability
Solid model experience (ProE or SolidWorks)
Strong foundation in design, fabrication and assembly of complex assemblies
Excellent communication and documentation skills
Demonstrated ability to represent the company to its partners, suppliers, and vendors
Comfortable interacting with technicians, engineers, and management
Strong technical skills in prototyping and troubleshooting from engineering documentation
Demonstrated ability to successfully work on multiple projects at once
ISO9001/13485 or experience in medical device manufacturing environment
Moving or lifting equipment/product up to 30 lbs. occasionally required
Machine tool experience a plus |
(IQ OR OQ OR IQ/OQ OR FIXTURES OR TOOLS OR DESIGN OR ASSEMBLY) AND ("MEDICAL DEVICE" OR "MEDICAL DEVICES" OR ISO9001) AND ("MECHANICAL ENGINEERING" OR "MECHANICAL ENGINEER" OR ELECTROMECHANICAL OR "PROCESS ENGINEERING" OR "PROCESS ENGINEER" OR "MANUFACTURING ENGINEER" OR MANUFACTURING) AND (SOLIDWORKS OR PROE)
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Mechanical or Industrial Engineering |