Engineer, Technical Complaints Investigator Drug Delivery Devices - (JP14915)

Job Title: Engineer, Technical Complaints Investigator Drug Delivery Devices - (JP14915) Location: Thousand Oaks, CA. 91320Employment Type: ContractDuration: 6+ months (with possible extension)Posting Date: 01/15/26Pay Rate: $36 - $41/hour W2Notes: Only qualified candidates need apply. Local candidate must be onsite as needed (approximately 80%.3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical 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 Sr. Engineer in Complaints Trending and Investigation group. The Complaints Trending and Investigation group here 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 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 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.Why is the Position Open?Coverage for partners leave of absenceTop Must Have Skills:Master's or Bachelor's in Engineering, Electrical, Mechanical or Science.Experience in lab environmentStrong technical writing and interpersonal skillsDay to Day Responsibilities:Perform device assessments of complaints and document results in a report.Complete evaluation and deliver assessment report on time per client's requirements.Support the implementation and management of the lab infrastructure, including all equipment used for investigationsProvide requirements for lab and investigational equipment to device development teams in support of new device platformsSupport characterization testing and data gathering for investigationsBasic Qualifications:Master's degree; ORBachelor's degree and 2 years of related exp in engineering - Electrical, Mechanical, medical/biopharma development or Operations experience; ORAssociate degree and 6 years of related medical/biopharma development or Operations experience.Preferred Qualifications:Master's or Bachelor's in Engineering, Science or Biomedical2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environmentExperience in lab environmentDemonstrated competency in root cause analysis methodologyExperience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)Strong technical writing and interpersonal skillsResults-driven and detail-orientedEmployee Value Proposition:Red Flags:"Lab exposure" without specific tools or methodsNo mention of testing equipment or analytical methods usedVague statements like "supported investigations" with no technical detailPurely desk based jobs without any lab environment mentionedDegrees unrelated to technical or scientific fieldsCourses/skills suggesting low technical aptitudeGeneralist resumes with very high-level descriptions-No measurable achievements or quantified resultsInterview process:We will begin by reviewing candidate resumes, conduct phone screens to identify the top three candidates, and then schedule online video interviews. From those interviews, we will select the final candidate to extend an offerWe invite qualified candidates to send your resume to resumes@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.Regards,