Industrial Engineer

4 weeks ago

Toronto, Canada FiúnEx Full time

About FiunEx:

FiúnEx is a highly specialized profit improvement operation consulting and Engineering service firm, which has a proven track record in flawless execution of projects in over 25 countries. We have a developed a niche in Life Sciences sector driving majority of our revenues. Through our unique engagement model and its success, we have experienced extremely tremendous growth in a short duration. We now have presence in US, Europe, & Asia. For more details on company, visit our website at www.fiunex.com.


Location: Toronto, Canada


RESPONSIBILITIES


The work involves producing high quality goods efficiently using the most cost-effective methods and with the aim of reducing the impact of production on the environment.

  • Manage the successful scale up and commercialization of this new process ensuring that target yield, capacity, throughput time and productivity are achieved
  • Monitor and analyses opportunities for the development of new or improved tools for process improvement activities
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs
  • Perform a Level-by-Level Material BOM Explosion to verify that the correct routing and costing has been utilized.
  • Identify process gaps from within manufacturing all the way through to final packaging after sterilization.
  • Adhering to plant EHS policies/procedures, report hazardous conditions or risks, follow department EHS rules, and PPE requirements.
  • Follow Good Manufacturing Practices (GMP’s), ISO 13485 regulations and Good Housekeeping procedures.
  • Perform studies of existing conditions related to the problem presented and analyze required changes to achieve increased production output and/or reduce product/process defects and waste.
  • Process Procedures, Drawings, Standard Work Instructions & tribal knowledge not documented.
  • Evaluate SOPs and visual aids and present improvement opportunities if any to support capacity expansion and outsourcing.
  • Evaluate the Quality Control procedures and checks in place are acceptable to meet the product quality & specifications and facility QMS.
  • Review proficiency requirements are clear before an operator is called certified to complete tasks independently with quality and compliance.
  • Provide weekly/monthly OpEx updates including key metrics to the organization and maintain Lean manufacturing visuals throughout the focus factory.
  • Use and understand Statistical based software and Quality tools (i.e., Process Maps, C&E Matrix, FMEA, and Design of Experiments) for warranting process changes or continuous improvements.
  • Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
  • Compose and execute validations and changes per the change control process.
  • Work with other professionals, such as accountants and human resources personnel, to manage budgets and the recruitment of junior engineers
  • Tendering for new equipment to ensure the highest quality at the best price
  • Organize plant start-up and shut-down schedules to ensure minimum loss of production time and profits.


DESIRED SKILLS AND EXPERIENCE


  • Relevant and recent experience in project / process engineering in a highly regulated environment.
  • Degree qualification in Mechanical or Industrial Engineering
  • Strong Analytical and Technical problem-solving skills
  • Self-motivated person that can work individually and lead team projects.
  • Previous experience working as a Mechanical Industrial Engineer. Demonstrates strategic thinking and drives continuous improvement in day-to-day activity.
  • Ability to develop production and system documentation
  • Strong communicator and proven ability to work within a team environment and maintain focus on key objectives.
  • Technical proficiency in all modern Automation & Process technologies and applications
  • Competent in the understanding and application of Six Sigma and Lean Manufacturing Techniques
  • Technical knowledge of polymer materials used in the manufacture of medical devices
  • Sound technical engineering approach to project management and problem solving
  • Experienced with all the Microsoft Office software applications for generating office documents, spreadsheets, project plans, etc.

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