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Manufacturing Engineer, Caesarea, Israel

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Engineering
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1900070S Requisition #
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Careers that Change Lives

Mazor Robotics  Ltd,  a Medtronic company since December 2018, is a global pioneer of robotics technology for use during spinal procedures. Our site is now focused on developing and supplying high quality, innovative surgical planning and robotic solutions/products.  Join us in working at a local and friendly site with global impact and reach.

A Day in the Life

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.

Working Relationships:

Internal: R&D departments, QA/RA, Operations and Product

External: Suppliers, Sub-Contractors, Contract Manufacturing


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 & manufacturing environments of multi-disciplinary products in Medical Device companies.
  • Prior experience with some of the following: complex machined parts, sheet metal Pneumatics, Motors, plastics, cable assemblies, PCBA.
  • Experience with design of Jigs, fixtures & Packaging.
  • Experience with Process Validations and qualification of equipment IQ/OQ/PQ, pFMEA.  
  • Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA.
  • Excellent communication skills, both verbal and written in English & Hebrew
  • Proven working experience with Solidworks – Mandatory.
  • Office proficient, experience with PDM/PLM systems, Priority.
 Other Requirements for the role ((% of travel, etc.) :
“Hands on”, Independendent, quick learner and a team player.

Ability to set work direction, work independently, and communicate with a vast network of global stakeholders.


Nice to Haves
  • Experience with design of surgical tools – Advantage
  • Green/Black Belt skills and experience – Big Advantege
 Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button!

About Medtronic

Mazor Robotics, Ltd., a Medtronic company .
Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the

future.
 

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. 


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