Sr Engineer - Technical Investigator

Role Summary

Sr Engineer - Technical Investigator

Responsibilities

• Lead root cause analysis to identify the failure mode for Amgen’s products and associated components due to product complaint
• Perform failure analysis using tools and processes 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. Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines 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
• Lead technical trend and consolidated investigations, including statistical assessment of data to identify cause of trends
• Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
• Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
• Develop and perform relational data analytics in support of investigations
• Advise management for trend and failure investigation process improvement
• Provide input to engineering for product improvements
• Coach and mentoring to junior engineers
• Support functional management initiatives and objectives
• Lead investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 10 years of medical/biopharma development, engineering or postmarket experience OR
  • Associate’s degree and 8 years of medical/biopharma development, engineering or postmarket experience OR
  • Bachelor’s degree and 4 years of medical/biopharma development, engineering or postmarket experience OR
  • Master’s degree and 2 years of medical/biopharma development, engineering or postmarket experience OR
  • Doctorate degree
• Preferred Qualifications:
  • Master’s Degree in Engineering or Science
  • 10+ years of progressive and relevant experience
  • 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
  • Proven experience with mechanical and/or electromechanical 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

Skills

• Root cause analysis
• Data analytics and statistical analysis
• Risk assessment and management
• Project leadership and cross-functional collaboration
• Technical writing and communication
• Mentoring and coaching

Education

• As listed in Basic/Preferred Qualifications