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Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15323)

3key Consulting, Inc.

Job Title: Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15323) Location: Thousand Oaks, CA 91320 Business Unit: Complaints Investigations Employment Type: Contract Duration: 12 months with likely extensions and/or conversion to permanent Rate: $40 - $46/hour W2 with Benefits Posting Date: 05/04/2026 Notes: Onsite 80%, must be available to go onsite when needed. Preferably Local candidates Job Description We are recruiting an Engineer for a consulting engagement with a leading global biotechnology company. The role is a complaints investigation technical investigator in the Complaints Trending and Investigation group. This position reports to a Sr. Engineer in the same group. The group works to continuously improve clinical and commercial drug delivery devices to ensure supply and optimize patient experience. The technical investigator performs device assessment of complaint samples using lab equipment such as CT scanners and Instron testing machines. They author assessment reports, communicate findings and results to management and cross‑functional teams, and ensure validity and integrity of evaluation reports. The investigator maintains close interaction with the quality complaints owner and supports investigations by performing characterization testing, data gathering and analysis, and leading/root‑cause analysis. They also support the implementation, validation, and operation of lab equipment, provide personnel training, develop and update equipment procedures, participate in monthly lab safety inspection, and identify and report equipment repairs or maintenance. They work with vendors to resolve issues and suggest equipment improvements. Job Responsibilities Perform device assessments of complaints and document results in a report. Complete evaluation and deliver assessment report on time per company requirements. Support 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. Day to Day Responsibilities Perform device assessments of complaints return units in lab and document results in a report. Complete evaluation and deliver assessment report on time per company requirements.Support implementation and management of the lab infrastructure, including all equipment used for investigations. Perform root cause analysis investigations for mechanical and/or electromechanical products (as needed). Basic Qualifications Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience. 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 lab environment. 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. Demonstrated competency in root cause analysis methodology. Top Must Have Skill Sets Experience in lab environment. Able to collaborate and communicate with cross functional team. Experience in technical investigation and root cause analysis. #J-18808-Ljbffr 3key Consulting, Inc.

Vacancy posted 4 days ago
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