Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557)

3 Key Consulting•Thousand Oaks, CA

7d•Onsite

About The Position

This position is for an Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices within the Complaints Trending and Investigation group. The role involves performing device assessments of complaint samples using laboratory equipment, authoring assessment reports, and communicating findings to management and cross-functional teams. The investigator will ensure the validity and integrity of evaluation reports and maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations through characterization testing, data gathering and analysis, and root cause analysis. The role also involves supporting the implementation, validation, and operation of lab equipment, training personnel, developing procedures, and participating in lab safety inspections. Collaboration with vendors to resolve equipment issues and suggest improvements is also part of the role.

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.