Required Manufacturing Engineer, Caesarea, Israel.
1900070W.
This engineering position supports the Supplier Excellence program within the Mazor engineering organization. This position conducts engineering activities in support of manufacturing operations, which may include: process improvements, component and material changes, implementation of product design changes, Value Analysis / Value Engineering (VAVE), process validation (IQ, OQ, PQ), and manufacturing process transfer activities.
This position conducts engineering activities and tasks in support of manufacturing requirements.
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Develop and implement design improvements from design freeze and during mass-production.
Design, qualify, document and validate: assembly & test fixtures/Jigs and tools, release to production and service.
Performs root causes analysis and implement corrective actions on equipment and manufacturing process issues.
Support on-going production processes and equipment, train subcontractors & production line. Identify and implement opportunities for continuous improvement.
Creating or improve manufacturing assembly and testing instructions, production and assembly instructions.
Provides technical evaluation and implementation plan input to the Corrective Action/Preventive Action (CAPA) program.
Construction and management of product DMR including BOM, SOP's, Mechanical & electrical specs.
Configuration management and Implementation of Engineering Changes/ECO.
Identify, lead and implement data-driven quality, manufacturing, and cost improvement projects.
Demonstrated experience leading engineering projects through phases of project lifecycle. Ability to use basic project management tools including project milestones, project schedules, resource management, and budget management.
Ensures all engineering activity is in full compliance with applicable Mazor quality system requirements, regulatory approvals, and other agency requirements as-identified.
Collaborate with suppliers and Contract Manufacturers to design, characterize and qualify high capability processes producing consistent finished device medical products. This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.
Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
Provide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvements. Provide focus and clarity for continuous improvements using Key Performance Indicator (KPI) metrics.
Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation, and Statistical Process Control (SPC).
Continuous improvement as a method for identifying opportunities for streamlining processes and reducing waste.
Promote Value Analysis/Value Engineering as a systematic process to creatively assess and generate alternatives to identify essential functions at the greatest value. Value engineering through the systematic method to improve output by using rigorous examination of function.
Implementation of manufacturing transfer requirements, for transition of products from Mazor to Contract Manufacturing, or between Contract Manufacturing facilities.
דרישות:
Must Haves
BSc.in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or similar relevant discipline.
Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD
At least five (5) years proven experience in Engineering & המשרה מיועדת לנשים וגברים כאחד.