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Engineer, Drug Delivery Device Complaints and Investigations (JP14565)
Engineer, Drug Delivery Device Complaints and Investigations (JP14565)3key Consulting, Inc. • Thousand Oaks, CA, US
Engineer, Drug Delivery Device Complaints and Investigations (JP14565)

Engineer, Drug Delivery Device Complaints and Investigations (JP14565)

3key Consulting, Inc. • Thousand Oaks, CA, US
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Overview

Job Title : Engineer, Drug Delivery Device Complaints and Investigations (JP14565) | Location : Thousand Oaks, CA 91320 - Hybrid | Business Unit : Complaints Investigation | Employment Type : Contract | Duration : 1+ years with possible extensions or conversion to FTE | Rate : $38 - $42 / hour W2 with benefits | Posting Date : 09 / 24 / 2025

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. The project involves investigations of complaints for device delivery systems and related reporting in support of patient safety and product quality.

Responsibilities

  • Perform device assessments of complaints and document results in a report.
  • Complete evaluation and deliver assessment report on time per company requirements.
  • Support the implementation and management of the lab infrastructure, including all equipment used for investigations.
  • Provide requirements for lab and investigational equipment to device development teams in support of new device platforms.
  • Support characterization testing and data gathering for investigations.
  • Perform root cause analysis investigations for mechanical and / or electromechanical products.

Top Must Have Skill Sets

  • Technical background preferably in a GxP setting.
  • Laboratory experience – comfort with technical testing.
  • Strong technical writing and interpersonal skills.

    • Preferred Qualifications

  • Master's or Bachelor's in Engineering, Science or Biomedical.
  • 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment.
  • Experience in a lab environment.
  • Demonstrated competency in root cause analysis methodology.
  • Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP).
  • Strong technical writing and interpersonal skills; results-driven and detail-oriented.
  • Strong sense of responsibility and time management.

    • Basic Qualifications

    Master's degree and 3 years of related medical / biopharma development or Operations experience; OR Bachelor's degree and 5 years of related medical / biopharma development or Operations experience.

    Additional Qualifications (Preferred)

  • Bachelor's, Master's or PhD in Engineering, Science or Biomedical.
  • 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment.
  • Experience with statistics and statistical analysis.
  • Demonstrated competency in root cause analysis methodology.
  • Experience with protocol and report writing, process and test development and execution, and writing SOPs.
  • Strong technical writing and interpersonal skills.
  • Results-driven and detail-oriented team leader.

    • Other considerations

    Why is the Position Open? Supplement additional workload on team.

    Interview Process : Virtual Interview; Interview with Hiring Manager; Panel Interview with team.

    Important notes

    We invite qualified candidates to send their resume to resumes@3keyconsulting.com. Additional positions may be available at www.3keyconsulting.com / careers.

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    Device Engineer • Thousand Oaks, CA, US