Process Engineer

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.