Associate Engineer, Biotech Product Complaint (JP13929)

3 Key Consulting • Thousand Oaks, CA

7d • Hybrid

About The Position

Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer 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 patient experience. The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, 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 CT&I 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

• Strong technical, analytical and problem-solving skills
• Strong interpersonal, communication, and teamwork skills
• Skills and experience in lab environment

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 in 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

Responsibilities

• Perform device assessments of complaints and document results in a report.
• Perform root cause analysis investigations for mechanical and/or electromechanical products
• Complete evaluation and deliver assessment report on time per Company’s 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 device assessments of complaints using equipment such as CT scanner, microscope and other measurement/imaging equipment in a laboratory environment and document results in a report.

What This Job Offers

• Career Level: Entry Level
• Education Level: No Education Listed