Intermediate Product Reliability Engineer

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 and clear documentation of conclusions.
• Maintain and interpret test card metrics for field performance; investigate correlations to materials, processes, and in-house results to enable more predictive performance models and proactive responses.
• Provide general guidance and training support to newer team members (e.g., onboarding, review of analyses, sharing best practices) and contribute to development of procedures, protocols, and technical documentation.
• Participate in external data generation/benchmarking activities at customer sites
• Support design transfer activities for new product development into production, as required.
• Required Knowledge/Skills, Education, and Experience
• Undergraduate degree in an appropriate technical discipline (e.g., Engineering, Science, or Technology) and/or an equivalent combination of technical experience and education.
• Minimum 3 years of relevant industrial experience
• Demonstrated proficiency using statistical tools and methods for product performance evaluation (e.g., trending, hypothesis testing, regression, distribution concepts) and translating results into clear conclusions and actions.
• Ability to independently solve assigned, non-routine technical problems, including defining the question, structuring analyses, and driving cross-functional alignment on next steps.
• Working knowledge of product testing and control strategies and ability to evaluate suitability of methods/protocols against intended use.
• Ability to develop a thorough understanding of the operating principles of the sensor sub-system, including calibration concepts/data analysis and the manufacturing/finished goods release process.
• Effective written and verbal communication skills for technical documentation, cross-functional collaboration, and stakeholder updates.
• Ability to provide general guidance and training support to junior staff (as assigned) and to work effectively in a team environment.
• Preferred Knowledge/Skills, Education, and Experience
• Advanced degree in an appropriate technical discipline (e.g., Engineering, Scien

Benefits

Additional Information

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. 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. 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.

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