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Process Engineer

3 months ago


Old Toronto Ontario, CA KNG Technical Inc. Full time

The Process Engineer is responsible for assisting with projects from origination through implementation. Primarily accountable for planning, coordinating and directing a project or process ensuring that organization standards, procedures and work processes are followed.

MAJOR DUTIES

  • Work to understand manufacturing requirements for customer needs.
  • Utilize quality management procedures for project implementation (design control, ECO, etc).
  • Communicate design requirements to Operations including adherence to specifications and standards.
  • Control and manage ECR process during prototype and production builds on behalf of the engineering function.
  • Create inspection and audit records/reports in accordance with quality management system.
  • Create routings and assembly instructions for production.
  • Work with the Engineering & Quality departments to create new internal standards and SOP (Standard Operating Procedures).
  • Participate in technical customer audit and interpret customer specific requirements and standards.
  • Specify new manufacturing equipment, fixtures, tooling, and workflow.
  • Create test methods for validating new products following approved quality management processes.
  • Optimizes work processes - Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.

PERFORMANCE AFFECTING PRODUCT QUALITY

  • Equipment Maintenance and Housekeeping
  • Design and Development
  • First Article Review Validation
  • Process Capability
  • Control of Design Change
  • Validation of Processes
  • Equipment Validation

AWARENESS AFFECTING PRODUCT QUALITY

  • Preservation of Product
  • Inspection and Test of Product
  • Control of Nonconforming Product
  • Corrective Action
  • Receiving Inspection
  • Shipping Operations
  • Control of Documents
  • Purchasing Process
  • Preventive Action
  • Inventory Procedures
  • Record Control
  • Standard Machine Shop
  • Software Validation
  • Shelf Life Control
  • Recall and Advisory Notice
  • Health and Safety
  • Labeling
  • Planning Operations
  • Customer Order
  • Analysis of Data
  • Calibration of Equipment

WORKING RELATIONSHIPS

Customers, internal departments, suppliers and other external bodies.

POSITION REQUIREMENTS

  • University Degree in Engineering (Mechanical or Electrical preferred).
  • Current license with PEO preferred.
  • Medical Equipment Manufacturing experience preferred.

4.PMI or PMP certification preferred or equivalent experience.

  • Minimum of three years manufacturing experience, preferably in a high volume environment.
  • Understanding of electrical and electronic schematic diagrams, blueprints and pneumatic/hydraulic systems.
  • Knowledge of LPS and LPS tools (i.e. value stream mapping).
  • Previous experience with the use of statistical analysis software and computer-assisted design, manufacturing and machining (i.e. AutoCAD and SolidWorks).
  • Ability to work; in a multi-task environment, with multiple projects, with cross functional teams and independently.
  • Strong knowledge of Good Engineering Practices, current GMPs, building codes and applicable legislation.
  • Sound analytical, problem solving and decision-making skills.
  • Excellent project management skills and ability to handle multiple complex projects.
  • Strong interpersonal, leadership, negotiation, organization and conflict resolution skills.
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