Product Reliability Engineer

Senior Product Reliability Engineer Location Ottawa, ON K1G 3P5 : Join us in pioneering breakthroughs in healthcare. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Under the supervision of the Manager, Assay Performance and Support, the Senior Product Reliability Engineer is responsible for managing and contributing to correct sensor calibration, monitoring of ongoing product performance, and technical consultation for sensor-related complaints.

Deep understanding of all aspects of how the sensors are designed to work (including the requirements for the software that converts raw signals to analytical outputs), how they are manufactured, how they are tested, and how the results of all these activities tie together to produce the overall sensor performance

• • Applying this knowledge to correctly calibrate the sensor and ensure, in collaboration with the Technical Operations group, acceptable ongoing performance of the sensor
• •Other duties, such as improving product testing procedures or supporting/executing field performance studies may also be assigned.

Interface with stakeholders to identify opportunities with data to drive solutions or improvements

• •Own and deliver technical projects related to assay development and design change
• •Ensure that analysis of calibration data for the sensors proceeds in a timely and correct manner so that accurate sensor configuration files can be generated as required
• •Establish and verify primary Value Assignments for the sensors, related to calibration, and including process improvement for test methodologies
• •Drive continuous review of product testing results (e.g., Finished Goods, Stability) to ensure manufactured sensors are behaving correctly and that product testing methods and protocols are appropriate and optimal
• •Ensure that adverse trends in the sensors' performance are communicated to appropriate groups and action taken to correct the trend
• • Design and implement improved control algorithms for monitoring sensor analytical performance as well as for sensor parameters that may predict analytical performance
• Lead sensor improvement initiatives that may have impact on the sensor calibration process or sensor performance.
• Provide technical troubleshooting/consultation support to service teams, Regulatory affairs, or customers.
• •Maintain test card metrics for product field performance and investigate correlations with respect to in-house results, materials, and processes to facilitate more predictive performance models and proactive responses
• •Assist in developing procedures, protocols, and other documentation to support quality and field performance.
• •Contribute to the design and implementation of efficient and reliable automation approaches to data gathering, visualization, and reporting related to product performance.
• Initiate and/or participate in external data generation or benchmarking opportunities at customer sites as required

Undergraduate degree Engineering, Science, or Technology and/or an equivalent combination of technical experience and education

• •Minimum 4 year of industrial experience
• •Knowledge of advanced statistical techniques and concepts (e.g., regression, properties of distributions, statistical tests)
• •Experience with development of product testing and control strategies
• •Experience with product development and management in a regulated industry such as pharmaceuticals or medical devices
• •Ability to deeply understand the operating principles of electrochemical sensors, the concepts and data analysis required for sensor calibration, and the manufacturing/finished goods release process

Advanced Degree in Engineering, Science, or Technology and/or an equivalent

combination of technical experience and education

Experience with specialized techniques for handling large data sets

Experience with Risk Analysis and Root Cause Analysis tools •

Good scripting and programming skills

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