Job Description
DESCRIPTION:
Remote for now but may eventually be required on site, so candidates within close proximity to Thousand Oaks are ideal Must have engineering design experience within the Biotech or Pharmaceutical industry. 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. RESPONSIBILITIES: • Understand customer / patient use of Amgen’s packaged and/or distributed mechanical and/or electromechanical products • Understand manufacturing processes for Amgen’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 BASIC QUALIFICATIONS • Master’s degree; OR • Bachelor’s degree and 2 years of directly related engineering experience; OR • associate degree and 6 years of directly related engineering experience; OR • High School diploma/GED and 8 years of directly related engineering experience PREFERRED QUALIFICATIONS • 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
TOP 3 MUST HAVE SKILL SETS:
Company Description
We are a technology solutions company helping organizations accelerate their business innovation and growth through project and talent solutions.