Industrial Waste Engineer

2 weeks ago

Toronto ON, 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

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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