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

3 Key Consulting•Thousand Oaks, CA

16d•Hybrid

About The Position

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. This position will be in the Complaints Trending and Investigation group. In support of the company’s mission to serve patients, the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience. The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis. S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Requirements

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
Experience in lab environment
Able to collaborate and communicate with cross functional team
Experience in technical investigation and root cause analysis

Nice To Haves

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 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

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