Intermediate Product Reliability Engineer

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Position Overview



* Under the supervision of the Manager, Assay Performance and Support, the Intermediate Product Reliability Engineer is responsible for ensuring continued correct sensor calibration, monitoring ongoing in-house and field product performance, and providing technical consultation for sensor-related complaints.


* Applies and expands reliability and statistical methods to solve non-routine product performance issues that may vary in size and nature, considering upstream manufacturing processes and downstream customer use conditions.


* Develops thorough professional know-how of the sensor sub-system (sensor chemistry/physics, software conversion of raw signals, manufacturing/test methods, and release criteria) and uses this knowledge to improve calibration robustness and performance monitoring strategies.


* Provides general guidance and day-to-day technical support to junior staff/co-op students and contributes to cross-functional initiatives with Technical Operations, Quality/Regulatory, and Service teams.

Responsibilities



* Independently execute and review sensor calibration data analysis to ensure accurate sensor configuration files are generated on schedule; identify data anomalies and drive resolution with appropriate stakeholders.


* Develop and implement improvements to calibration approaches (e.g., configuration logic updates, data filters, acceptance criteria) and document changes in accordance with the quality system.


* Establish and verify primary Value Assignments for sensors and support continuous improvement of associated test methods and verification activities.


* Perform regular, data-driven review of finished goods, stability, and other product testing outputs to confirm sensors are behaving correctly; recommend updates to methods/protocols when opportunities are identified.


* Monitor field and in-house performance metrics; communicate adverse trends to cross-functional groups and coordinate or support root cause analysis and corrective actions.


* Design and implement improved control algorithms/analytics for monitoring analytical performance and leading indicators of future performance; contribute to automation for data gathering, visualization, and reporting.


* Support and/or lead discrete technical projects related to assay improvements, test strategy, or design changes, coordinating inputs across R&D and Technical Operations as needed.


* Provide technical troubleshooting/consultation support to Service teams, Regulatory Affairs, Quality, or customers; ensure timely follow-up an...