Engineer, Complaints Investigation Medical Devices (JP11459)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Engineer, Complaints Investigation Medical Devices
(JP11459) Location: Thousand Oaks, CA. 91320 Business Unit:
Complaints Investigations Employment Type: Contract Duration: 12
months (with likely extensions and/or conversion to permanent!)
Rate : $37 - $43/hour W2 Posting Date: 5/17/23 Notes: Only
qualified candidates need apply. Local candidates only. Onsite 80%
of time. 3 Key Consulting is recruiting an Engineer for a
consulting engagement with our direct client, a leading global
biotechnology company. automotive manufacturing and services
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
Manager in Complaints Trending and Investigation group. 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. Top Must Have Skill Sets: Experience in technical
investigation and root cause analysis Master’s or Bachelor’s in
Engineering, Science or Biomedical Experience in lab environment
Able to collaborate and communicate with cross functional team Day
to Day 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
client 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 Basic Qualifications: Master’s degree; OR Bachelor’s
degree and 2 years of related medical/biopharma development or
Operations experience; OR Associate degree and 6 years of related
medical/biopharma development or Operations experience. 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 Why is the Position Open?
Supplement additional workload on team. Red Flags: No technical
background or experience Lack of basic technical qualifications and
must have skills Inability to commute to Thousand Oaks Facility
Interview Process: Phone screening (15-30 min with hiring manager)
Video call / interview with cross-functional team (3-4 members, 30
min each) We 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, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Fountain Valley , Engineer, Complaints Investigation Medical Devices (JP11459), Engineering , Thousand Oaks, California
