Complaints Technical Investigator

Our Client is currently seeking an Engineer - Complaints Technical Investigator. In support of their mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation

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Responsibilities

• Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends.
• Provide input to engineering for product improvements.
• Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms.
• Lead root cause analysis to identify the failure mode for products and associated components due to product complaint.
• Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, risk assessments such as FMEAs, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
• Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation.
• Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
• Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use

Basic Qualifications:

• Master degree
• Bachelor degree and 2 years of experience
• Associate degree and 6 years of experience
• High school diploma / GED and 8 years of experience

Preferred Qualifications:

• Masters Degree in Science
• 5+ 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
• Understand customer / patient use of packaged and/or distributed products
• Understand manufacturing processes for packaged and/or distributed products
• Proven experience with medical devices
• Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
• Experience with 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, and design of experiments
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Strong technical writing and interpersonal skills