Senior Engineer (JP4837)

Location: Thousand Oaks, ca
Date Posted: 10-15-2018
Job Title:  Senior Engineer (JP4837)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Sustaining Engineering
Duration: 1+ years (likely extensions)
3Key Consulting Inc. is recruiting for a Senior Engineer with 2 - 5 years’ experience in R & D and commercial product complaint handling and investigation for injectable medical devices for a global, CA-based, bio-pharmaceutical company.
Job Description:
The engineer will support technical investigations of combination product complaints associated with product design, manufacturing, 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 authoring final reports in accordance with established procedures. This person will own 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 device engineering and quality functions to contribute to product improvement.
Top Must-Have Skill Sets:
  • Complaint handling and investigation.
  • Injectable devices (2-5 years of experience in the Field).
  • Failure analysis and root cause analysis.
Day to Day Responsibilities
Mechanical and electromechanical injectable devices combination products complaint handling and investigation.  Responsibilities include:
  • 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.
  • CAPA ownership in support of ideation phase.
  • Provide input to management for trend and failure investigation process improvement.
  • Support functional management initiatives and objectives.
  • Support functional management initiatives and objectives.
Basic 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/or Class III.
  • Demonstrated experience with mechanical and/or electromechanical medical devices; preferably needle based injection system – syringe, autoinjector, infuser.
  • Demonstrated applied 6 Sigma competency, specifically for root cause analysis methodology.
  • Knowledge of Quality System Regulation – 21CFR820, ISO-11608, and 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.
Why This Position Is Open:
Need more resources to support device support. Typically deal with mechanical injectors but now needs to deal with electro-mechanical devices.
Employee Value Proposition:
This is a combination product. Would gain experience in both drug product and device areas.
Red Flags:
This person cannot be only interested in Research and Development. This is dealing with commercial product as well.
Interview process:
Phone interview followed with on-site interview.

We invite qualified candidates to send your resume to  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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