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Company | Lonza |
Address | Kingston, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-31 |
Posted at | 10 months ago |
Canada, Kingston
- Adheres to design and development principles, and employs prototyping and testing methodology
- Stewards the Design History File and Device Master Record through thorough documentation of specification updates, design verification, design information, risk assessments, etc.
- Participates in collaborative and complex design updates and implementations of corrective actions and backlog features related to product design within a cross-functional team
- Investigates product complaints and non-conformances, performs root cause analysis of failures, and proposes corrective actions in a timely fashion
- Generates and reviews technical documentation including investigative pursuits, conceptual design, mechanical drawings, and technical reports, all within a ISO 13485 Quality Management System
- Improves product quality and reliability, manufacturing efficiency and production yields through product design modification
- Develops and performs the verification activities on corrective designs
- Technical interface with vendors. Sources parts as required, and manages vendor issues as needed
- Reviews existing product designs, identifies weaknesses, proposes and implements improvements
- Applies a risk-based approach to product design activities using xFMEA methodology
- Independent work and initiative
- Demonstrated troubleshooting and problem solving skills – organized and detail oriented, hands-on
- Competency in mechanical analysis skills such as kinematics, fluid dynamics, heat transfer, material
- Excellent verbal and written skills – clear and concise communication
- Navigating processes and workflows required in regulated environments
- Bachelor’s degree in Engineering field; Mechanical Engineering preferred
- Extensive understanding of CAD systems – preferably SolidWorks
- Knowledge of manufacturing processes: machining, injection molding, 3D printing
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