| To perform this job successfully, an individual must have the necessary knowledge on Manufacturing process and quality topics.
The requirements listed below are representative of the knowledge, skill, and/or ability required:
Bachelor's Engineering in Mechanical / Electrical / Electronics with 6 to 8 years of experience in Manufacturing Process study and documentation of electro-mechanical products for Medical, Aerospace or Automotive Industry
Experience in Component Inspection and documentations, standard Work instructions for commodities such as printed circuit board assemblies, power supplies, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc..
Experience in SAP and Data Management.
Experience in regulated industry, Medical preferred
Knowledge of FDA standards such as 21 CFR Part 820, 21 CFR Part 11, ISO 13485, etc.,
Good teamwork skills, can work independently, not afraid to speak up, and works well with others
Primary Skills:
- BS in Electrical/Industrial/Mechanical Engineering
- 8 years working experience in Medical / Aerospace / Automotive Manufacturing quality process
- Experience in Inspection of electro mechanical commodities |
(Manufacture AND manufacturing) AND (Device OR Devices) AND Medical AND (Assembly Line)
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Automotive |
| 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 |
| 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")
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Medical Device |
| Warehouse Associate |
(MANUFACTURING OR ASSEMBLY OR ASSEMBLER OR ASSEMBLING OR ASSEMBLE OR PICK OR PICKING OR PACK OR PACKING OR PACKAGING OR PACKAGE OR SORT OR SORTING OR CARRY OR CARRYING OR SHIPPING OR STUFFING OR LIFT OR LIFTING OR LOAD OR LOADING OR UNLOAD OR UNLOADING OR STACK OR STACKING OR PALLET OR PALLETIZE OR WAREHOUSE OR PRODUCTION OR FORKLIFT)
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Warehousing |
| 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
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Medical Device |
| Warehouse Worker |
(MANUFACTURING OR ASSEMBLY OR ASSEMBLER OR ASSEMBLING OR ASSEMBLE OR PICK OR PICKING OR PACK OR PACKING OR PACKAGING OR PACKAGE OR SORT OR SORTING OR CARRY OR CARRYING OR SHIPPING OR STUFFING OR LIFT OR LIFTING OR LOAD OR LOADING OR UNLOAD OR UNLOADING OR STACKER OR STACKING OR PALLET OR PALLETIZE OR WAREHOUSE OR PRODUCTION OR FORKLIFT)
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Warehousing |
| Use this string for basic search of production machine operators in manufacturing. I.E. Press operator, zipper operator, laminator operator, extruder operator, etc. |
"production machine operator" AND (manufacturing OR assembly OR production)
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Packaging & Containers |
| Machine Operator - 1 |
("MACHINE OPERATOR" OR "CNC OPERATOR" OR "CNC MACHINIST" OR "CNC PROGRAMMER" OR "FORKLIFT OPERATOR") AND (MANUFACTURING OR ASSEMBLY OR PRODUCTION) AND (LATHE OR BLUEPRINT OR SKETCH OR SHEET OR DRILLING OR COUNTERSINKING OR OSHA) WITHIN 30 MILES OF 55317
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Aviation & Aerospace |