|Title:||Process Engineering - Contract Manufacturer of Medical Devices|
|Job Location:||Woodbridge North, Ontario - Canada|
|Salary:||$90,000.00 - $100,000.00 - Canadian Dollars - Yearly|
|Other Compensation:||Bonus + Full Benefits|
|Employer Will Recruit From:||Local|
This is one of the top 10 Medical Device Contract Manufacturers in North America. They have been really busy during the pandemic years manufacturing Face Shields and Class I Medical Devices for the NA market. Many projects in development at different phases and they are looking to grow their team.
Key Responsibilities include:
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.
Bachelor’s degree in Engineering. Current license with PEO preferred
Minimum 3 years manufacturing experience preferable in a high volume environment Medical device experience in an ISO 13485 certified environment
PMI or PMP certification preferred or equivalent experience
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. Contractor management skills.
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. Excellent computer skills.
Multi-faceted experience in plastics, metals and other materials Excellent communication skills (oral, written, technical). Excellent time management skills and the ability to be self-directed. Customer focus and continuous improvement approach. Experience with machining, fabrication, and assembly operations a plus.
University - Bachelor's Degree/3-4 Year Degree