Test Engineer, Technical Investigator, Medical Device (JP13934)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
|
|
|
Job Description:
Job Title: Test Engineer, Technical Investigator, Medical Device
(JP13934) Location: Thousand Oaks, CA. 91320 Business Unit:
Complaints Trending Employment Type: Contract Duration: 12 months
with possible extensions or conversion to FTE Rate : $36-42 W2 with
benefits Posting Date: 04/12/2025. Notes: Only qualified candidates
need apply. Onsite 80% of time as needed (local candidates). 3 Key
Consulting is hiring! We are recruiting an Engineer, Technical
Investigator Medical Device for a consulting engagement with our
direct client, a leading global biotechnology company. Ideal
candidate: 3 years of experience performing failure analysis
investigations within a medical device environment, specifically
class II or class III devices. Proficient with ISO systems, risk
analysis processes, and protocol or report writing. A bachelor's
degree in engineering or sciences such as chemistry, physics, or
biology is strongly preferred, though candidates with other
educational backgrounds who possess robust laboratory experience
will also be considered. Experience working in biohazard lab
settings is a plus, but not mandatory. Excellent written and verbal
communication skills, along with strong presentation abilities, are
essential as the role involves regular presentations to internal
teams. Candidates must have a background in medical devices,
biotech, or biopharma industries and must be local, able to commute
onsite 2–3 days per week (ideally residing within Los Angeles,
Orange, or Ventura Counties). This role will begin as a one-year
contract, with the potential for extension. Engineer - Complaints
Technical Investigator: Requires a combination of working remote
and going onsite 2 to 3 times per week (average) for complaint
returns assessment and/or laboratory equipment setup, development
and validation of test methods. Job Description: Our client is
currently seeking an Engineer - Complaints Technical Investigator
in our Complaints Trending and Investigation group. In support of
Company’s mission to serve patients, we are 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 Engineer - Complaints Technical Investigator
conducts forensic evaluations of complaint units for Standard and
Advanced complaint investigations associated with product design
and/ or usability issues. This role understands customer/ patient
use of Company’s packaged and/or distributed products, as well as
manufacturing processes for these products. Responsibilities also
include helping with Root Cause Analysis, investigation lab
infrastructure, equipment setup, and method development and
validation. Top Must Have Skill Sets: 3 years of experience in
failure analysis investigation within a development or
manufacturing environment, working with Medical Devices, ideally
Class II and Class III Experience with risk management per ISO
14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and
other Risk Management tools) Experience with protocol and report
writing, process and test development and execution, and design of
experiments Day to Day Responsibilities: Lead evaluation of
returned product, product reserve sample inspections, batch records
and review of complaint histories and trends Provide input to
engineering for product improvements Partner with device
engineering to develop structured failure analysis processes and
tools for current and future device platforms Lead root cause
analysis to identify the failure mode for Company’s products and
associated components due to product complaint Perform failure
analysis to identify root cause using processes and tools such as
fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault
Tree Analysis, or tolerance analysis. Additional equipment such as
CT scanners, Instron tensile test machines and SEM may be used.
Lead cross functional ideation of design solutions to reduce
complaints based on output of root cause analysis, determine
feasibility of options through testing and analysis, develop
business plans for implementation Generate final reports in
accordance with established procedures, which may include data
collection and statistical analysis of the data Help with
investigations lab equipment setup, develop and provide equipment
training to personnel, develop and validate test methods, and
develop SOPs for equipment use. Basic Qualifications: Master degree
OR Bachelor degree and 2 years of experience OR Associate degree
and 6 years of experience OR High school diploma / GED and 8 years
of experience Preferred Qualifications: Master’s Degree in Science
3 years experience in complaints or failure analysis investigation
within a development or manufacturing environment, working with
Medical Devices, ideally Class II and Class III Understand customer
/ patient use of Company’s packaged and/or distributed products
Understand manufacturing processes for Company’s packaged and/or
distributed products Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause
analysis methodology Experience with risk management per ISO 14971
(System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other
Risk Management tools) Experience with protocol and report writing,
process and test development and execution, and design of
experiments Experience in leading continuous improvement activities
by driving the implementation of process and product quality
improvement initiatives Strong technical writing and interpersonal
skills Why is the Position Open? Supplement additional workload on
team. Red Flags: Must be local to ATO or willing to relocate
immediately. Must be willing to be on site 2-3 days per week. Must
be familiar with good laboratory practices (GLP) Interview Process:
Interview with Sr. Engineer, Lab Captain, and Associate Director of
C&TI and others as necessary. 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, Cerritos , Test Engineer, Technical Investigator, Medical Device (JP13934), Engineering , Thousand Oaks, California
