Process Engineer – Medical Device Manufacturing


Published
March 19, 2021
Location
Vaughan, ON, Brampton, ON, Etobicoke, ON, Mississauga, ON
Category
Job Type
Employer
  • Brian Pho
Salary
$90,000 - $100,000 per annum + Bonus + Full Benefits
Travel Requirements
none
Start Date
ASAP

Description

Process Engineer – Medical Device Manufacturing
Location: Vaughan, ON
Salary: $90,000 - $100,000 per annum + Bonus + Full Benefits

We are looking for Process Engineer for a NA Based contract manufacturer and assembler of medical devices and sub components. The Process Engineer reports to the General Manager.  They will work closely with the Engineeering Director and Site Managers, with the principle goal to plan, direct, co-ordinate new product launches for new programs. Our client is a very busy and one of the top 10 Medical Device Contract Manufacturers in North America. 

 Your responsibilities will be:

  • Understand manufaturing requirements for customer needs. Project implementaion (Design control and Engineering Change Orders ECO)
  • Verification and Validation of new equipment and of new processes. From design, communicate design requirements and changes to Operations team to specifications and standards. Managing ECR process requests during prototype and production build as needed as an Engineering function.
  • Ability to be on the floor working with the machine operators and proposing new designs to assembly work stations. Creating SOP and assembly instructions for production. Working closely with Engineering and Quality departments to create new internal standards and SOP.
  • Participate in customer audits and customer specific requirement and standards as it relates to Manufacturing and Operations. Ability to recommend new manufacturing equipment, fixtures, tooling and workflow. 
  • Focus on Continuous Improvement and creating test methods for validating. Optimizing work processes. 

 

 

Requirements

You will need the following essential skills:

  • 4 year Bachelor Degree in Manufacturing Engineering or Mechanical Engineer. Current license with PEO preferred. 
  • Minimum of 3 years of Process / manufacturing experience in a highly regulated, high volume environment. Medical Device experience in an ISO 13485 Certified environment is preferred. Candidates from Electronic Manufacturing and Food Manufacturing would be considered if its the right fit.  
  • PMI or PMP Certification preferred or equivalent experience on managing service delivery of projects on a daily basis.
  • Understanding of electrical and electronic schematic diagrams, blueprints and pneumatic/hydraulic systems.
  • Knowledge of Statistical Analysis software and Computer aided design , manufacturing , machining, injection molding (AutoCad and / or SolidWorks)
  • Knowledge of GMP, analytical tools, Goods Engineering Process for Manufacturing and Operability. Knowledge of LPS and LPS Tools (Value Stream Mapping). 
  • Knowledge working with a variety of materials: Machining, CNC, Injection Molding, Welding.  (Plastics and Metals)

 

Additional Comments

This is a great contract manufacturer located in West Toronto, ON. They are in a growth mode during our pandemic times and there is financial security. Ability to control a project from the ground up (Cradle) to grave and manage it right to Quality . 

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