Engineer, Product Complaints and Investigations (JP11646) - Hybrid
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Product Complaints and Investigations
(JP11646) Location: Thousand Oaks, CA. 91320 - Hybrid Business
Unit: Complaints Trending Employment Type: Contract Duration: 1
years with possible extensions or conversion to FTE Rate : $37 -
$42/hour W2 Posting Date: 07/31/2023 Notes: Only qualified
candidates need apply. Must be local to be onsite a few days a
week. 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 an
engineer in our Complaints Trending and Investigation group. This
position will report to our Sr. Manager of Complaints Trending and
Investigation. The engineer will conduct technical investigations
of Level 2 and 3 complaints associated with product design and/or
usability issues, as well as conduct trend and consolidated
investigations using data analytics. S/he will be responsible for
the validity and integrity of the investigations and reports,
including the data and its statistical analysis. S/he will also
participate and/or lead in cross functional ideation of design
solutions. The engineer maintains close interaction with the device
engineering and quality management functions to contribute to
product improvement and management reporting. Additionally, s/he
will support the implementation and validation of the equipment in
the investigation lab. Responsibilities include: Lead root cause
analysis of mechanical and/or electromechanical products to
identify root cause using tools such as tolerance analysis,
fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or
Fault Tree Analysis Perform technical trend and consolidated
investigations, including statistical assessment of data to
identify trends, as well as generation of monthly reports Develop
and perform relational data analytics in support of investigations
Deliver reports and investigations on time per client and
regulatory requirements Understand customer / patient use of
client’s packaged and/or distributed mechanical and/or
electromechanical products Understand manufacturing processes for
client’s packaged and/or distributed products 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 Top Must Have Skill Sets: Technical
writing skill is a MUST Root cause analysis in an engineering
setting (should be able to truly perform root cause analysis not
just have experience in logging complaints) Strong ability to
analyze data generated from a variety of analytical techniques and
system is preferred Previous lab experience is helpful but not
required Day to Day Responsibilities: Assist senior engineers with
the following: Designing the study and drafting protocols.
Compiling historical data from different analytical systems.
Analyzing the data and presenting the results Writing summery
reports. Executing of the protocols includes testing in the lab
using vacuum decay leak tester, Instron force tester, balance,
microscope, pressure chamber, analytical measurement equipment’s
like caliper, optical comparator, bore gauges, automated stoppering
unit, pipits, and de-crimpers. Basic Qualifications: Master’s
degree and 3 years of related medical/biopharma development or
Operations experience; OR Bachelor’s degree and 5 years of related
medical/biopharma development or Operations experience; OR
Associate’s degree and 8 years of related medical/biopharma
development or Operations experience Preferred Qualifications:
Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical 2
years of experience in complaints investigation within a
development, manufacturing, post-market or equivalent environment
Experience with statistics and statistical analysis Demonstrated
competency in root cause analysis methodology Experience with
protocol and report writing, process and test development and
execution, and writing standard operating procedures (SOP) Strong
technical writing and interpersonal skills Results-driven and
detail-oriented team leader Why is the Position Open? Supplement
additional workload on team Red Flags: Candidate with a schedule
that is not flexible, possible OVT Bachelors degree not in
Bioscience or engineering degree Interview Process: Phone screen
followed by video interview 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, Buena Park , Engineer, Product Complaints and Investigations (JP11646) - Hybrid, Engineering , Thousand Oaks, California
