Engineer # JN -072021-67715
Posted on: July 28, 2021
Industry: Mechanical / Manufacture / Electrical Engineers
- The Engineer will support technical investigations of Level 2 and 3 complaints associated with product design and / or usability issues, and support trend and consolidated investigations using data analytics.
- S/he performs root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components such as packaging, returned due to product complaint using root cause analysis tools and processes.
- Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines may be used.
- S/he supports trend investigations through the review of manufacturing batch records, evaluation of returned product, product reserve sample inspections, and review of complaint histories and trends.
- Upon completion of these activities, s/he will support authoring final reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
- The Engineer maintains close interaction with the engineering and quality functions to contribute to product improvement.
- Understand customer / patient use of Client’s packaged and/or distributed mechanical and/or electromechanical products
- Understand manufacturing processes for Client’s packaged and/or distributed products
- Support technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
- Support cross functional ideation of design solutions based on output of root cause analysis
- Support the development and performance relational data analytics in support of investigations
- Support failure analysis of mechanical and/or electromechanical product to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree Analysis
- Provide input to management for trend and failure investigation process improvement
- Support functional management initiatives and objectives
- Master’s degree; OR
- Bachelor’s degree and 2 years of directly related engineering experience; OR
- Associate’s degree and 6 years of directly related engineering experience; OR
- High School diploma/GED and 8 years of directly related engineering experience
- Bachelor’s or Master’s Degree in Engineering, preferred Mechanical, Electrical, or BioMed
- 5 or more years of progressive experience as an engineer within the appropriate field of study
- 2 or more years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
- Demonstrated experience with mechanical and/or electromechanical medical devices
- Demonstrated applied 6 Sigma competency, specifically for root cause analysis methodology
- Knowledge of risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
- Experience with protocol and report writing, process and test development and execution
- Strong technical writing and interpersonal skills
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