Associate Engineer, Biotech Product Complaint (JP13929)
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
Hybrid remote
Compensation
$32-$36/hour
Job Description
Job Title: Associate Engineer, Biotech Product Complaint (JP13929)Location: Thousand Oaks, CA. 91320 - HybridBusiness Unit: Complaints TrendingEmployment Type: ContractDuration: 1+ years with possible extensions or conversion to FTERate: $32 - $36/hour W2Posting Date: 04/11/2025Notes: 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*
- 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
- Strong technical, analytical and problem-solving skills
- Strong interpersonal, communication, and teamwork skills
- Skills and experience in lab environment
- 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.
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FAQs About Associate Engineer, Biotech Product Complaint (JP13929) Jobs at 3 Key Consulting
What is the work location for this position at 3 Key Consulting?
This job at 3 Key Consulting is located in Thousand Oaks, California, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at 3 Key Consulting?
Candidates can expect a pay range of $32–$36 per hour for this role.
What employment applies to this position at 3 Key Consulting?
3 Key Consulting lists this role as a Full-time position.
What experience level is required for this role at 3 Key Consulting?
3 Key Consulting is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What is the process to apply for this position at 3 Key Consulting?
You can apply for this role at 3 Key Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.