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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.
Position Overview
- 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.
Responsibilities
- Guide and review the work of junior group members
- 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
- Improve epoc® System logic for the sensors to achieve better calibration outcomes
- 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
Required Knowledge/Skills, Education, and Experience
- 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
Preferred Knowledge/Skills, Education, and Experience
- 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
Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
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