: Engineer – Complaint Trending and Investigation (JP7357)
Thousand Oaks, CA. Remote then full-time on site after Covid-19 restriction is lifted.
: 12 months with likely extensions.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company, to support Complaint Trending and Investigation.
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. 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 data verification and/or authoring final reports in accordance with established procedures, which may include data collection and statistical analysis of the data. S/he will own Corrective/Preventive Actions (CAPA’s) in support of identifying design solutions based on root cause and will also support cross functional ideation of design solutions. The Engineer maintains close interaction with the engineering and quality functions to contribute to product improvement.
- Understand customer / patient use of company’s packaged and/or distributed mechanical and/or electromechanical products
- Understand manufacturing processes for company’s packaged and/or distributed products
- Support data verification activities, 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 (RCA)
- 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
- CAPA ownership in support of ideation phase
- 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
Top Must have Skill Sets:
- 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 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
Day to Day Responsibilities:
- Data Analytics
- Root Cause Analysis (RCA)
- Corrective/Preventive Action (CAPA)
- Bachelors or Masters Degree in Engineering - ideally mechanical/chemical/electrical/bioengineering.
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.
Employee Value Proposition:
This is a highly cross functional role from design and development tall the way to product implementation.
Unexplained gaps in employment
Weak communication skills
Lack of strong technical knowledge of core job requirements
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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