Associate Engineer, Biotech Product Complaint (JP14126)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Associate Engineer, Biotech Product Complaint
(JP14126) 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 -
$35/hour W2 Posting Date: 04/21/2025 Notes: Must be local to be
onsite 80% of the time. 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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Fullerton , Associate Engineer, Biotech Product Complaint (JP14126), Engineering , Thousand Oaks, California
