Job Title: Associate Engineer, Biotech Product Complaint (JP13929)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $32 - $36/hour W2
Posting Date: 04/11/2025
Notes: Must be local to be onsite.
3 Key Consulting is recruiting an
Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
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.
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
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
- 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
Top Must Have Skill Sets:- Strong technical, analytical and problem-solving skills
- Strong interpersonal, communication, and teamwork skills
- Skills and experience in lab environment
Day to Day Responsibilities:- 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.
- Onsite 80%, must be available to go onsite when needed.
Why is the Position Open?
Supplement additional workload on team
Red Flags:Short timer employment
No technical or engineering experience/education
Interview Process:
1st phone interview with hiring manager
2nd virtual interview with hiring manager and team.
We invite qualified candidates to send your resume to
recruiting@3keyconsulting.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.