| 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)
|
Mechanical or Industrial Engineering |
| Medical Device Technician |
(MECHANICAL OR ELECTRO-MECHANICAL OR CHEMICAL OR CHEMICALS OR ELECTRICAL) AND (R&D OR "RESEARCH & DEVELOPMENT" OR "R AND D" OR GMP OR MANUFACTURING) AND ("MEDICAL DEVICE" OR "MEDICAL DEVICES" OR "MEDICAL DEVICE ASSEMBLER" OR "MEDICAL DEVICE ASSEMBLY" OR ASSEMBLER OR "MEDICAL DEVICE TECHNICIAN")
|
Medical Device |
| Automotive companies |
(Toyota OR Chevrolet OR Fabco OR Ford OR Electriphi OR BMW OR honda OR Genera OR "Royal Truck" OR Udelv OR Spireon OR Motorsport OR "Motorcar" OR Nissan OR honda OR "Mitsubishi motors" OR Toyota OR "Lola's" OR "kia motors" OR "General Motors" OR Chrysler OR Subaru)
|
Automotive |
| Electro-mechanical Assembler |
(BUILD OR ASSEMBLER OR ASSEMBLY OR ASSEMBLE OR STRUCTURE OR PRODUCE OR MODIFY OR WELDER OR WELDING OR MECHANIC OR SCREW OR NUT OR DESIGN OR PRODUCTION OR LINE OR OPERATOR OR MACHINE) AND (ASSEMBLE OR ASSEMBLER OR ASSEMBLY) AND (ELECT OR MAGNET OR ELECTROMAGNET OR ELECTROMAGNETIC OR SOLDERING) AND MACHINE
|
Medical Device |
| CNC consultant for JDE Enterprise One |
(CNC Operator OR CNC Consultant OR CNC Specialist) AND (JD Edwards OR JDE Enterprise One) AND (Object Management Workbench OR OMW OR Object Librarian OR OL OR Data Dictionary OR DD OR Table Browser OR Debugging Tools OR Forms OR UBE reports OR Named Event Rule OR NER) AND (Business Functions) AND (Electronic Data Interchange OR EDI)
|
Information Services |
| CAD designer role |
"CAD Designer" OR "Electrical harnesses" OR "harness design" OR "Electrical Harnesses 2D – 3D" OR "2D" OR "3D" AND "Catia V5" OR "Catia V6"
|
Automotive |
| High Voltage Electrician |
"HV Electrician" OR "Maintenance Electrician" OR "Electrical Expert" OR "Electrical Worker" OR "High Voltage Electrician" OR "Electrical Engineering Technician" OR " Electrical Tradesman" OR "Electro-Mechanical Technician" OR "Electronic Equipment Technician" OR "Electronic Technician" OR "Engineering Technician" OR "Electrician" OR "Electrical Engineers" OR "Electronics Electrician"
|
Mining & Metals |
| Semiconductors companies |
Intel OR Qualcomm OR Broadcom OR "Texas Instruments" OR AMD OR "Micron Technology" OR "Applied Materials" OR Xilinx OR "Marvell Technology" OR Maxim OR "NXP Semiconductors" OR Cadence OR "Cypress Semiconductor" OR Microchip OR Teradyne OR "Lam Research" OR "Skyworks Solutions" OR "Western Digital" OR KLA OR Lattice OR Qorvo OR "Silicon Laboratories" OR Synaptics OR "Cirrus Logic" OR "Maximus Holdings" OR Entegris OR Inphi OR MACOM OR "Tower Semiconductor" OR "MKS Instruments" OR Ambarella OR "Semtech Corporation" OR Rambus OR Amkor OR FormFactor OR "Power Integrations" OR Synopsys OR Mellanox OR "NVIDIA" OR "Infinera Corporation" OR Cohu OR Diodes OR "Renesas Electronics" OR "Axcelis Technologies"
|
Semiconductors |