Engineer, Medical Device Test Design and Execution (JP12062)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer, Medical Device Test Design and Execution
(JP12062) Location: Thousand Oaks, CA. 91320 Business Unit: Systems
Engineering Employment Type: Contract Duration: 1 years (with
possible extensions) Rate : $37 - $41/hour W2 Posting Date:
12/05/2023 Notes: Only qualified candidates need apply. Onsite in
Thousand Oaks Mon through Fri with need to 6:00 AM calls to support
Demark time zone twice a week. Time on campus will be lab work will
be working with lab equipment. There is hybrid opportunity once
candidate is seen to be self-sufficient. 3 Key Consulting is
recruiting an Engineer, Medical Device Test Design and Execution
for a consulting engagement with our direct client, a leading
global biotechnology company. Job Description: The Mechanical
Engineer on the Combination Product Test Team will interact with
global and cross-functional members from systems engineering,
process engineering, device development, packaging, primary
containers, device quality, and other groups. Responsibilities of
this position include development, testing, transfer, and life
cycle management of multiple autoinjector device commercialization
efforts. Test activities will include Engineering, characterization
and GMP verification testing and will require a strong proficiency
in developing test protocols, statistical analysis, executing hands
on testing, and reporting of results to senior leadership. This
position will work side by side with experienced Device Test
Engineers authoring test protocols, executing test plans,
performing data analysis, and finalizing test reports. The
successful candidate will employ engineering skills and practices
to gather user requirements and translate them into technical
documentation for test execution and analysis. The position
involves support of senior staff in the initiation, design, and
delivery of projects milestones to support verification testing
activities. The chosen candidate will frequently spend time in a
lab environment working with various types of testing equipment
from manual measuring equipment through fully automated testing
systems. The devices that will be tested include various iterations
of handheld autoinjector drug delivery systems. This role will
include numerous collaboration sessions with the test team and
global team to trade best practices, discuss issues and
resolutions, and create a testing strategy. The chosen candidate
may also take part in design and fabrication of test fixtures and
processes. Our ideal candidate will have familiarity with medical
device engineering and applicable standards, preferably ISO
11608-1, and their application. Top Must Have Skill Sets: Strong
writing and technical authorship including experience in writing
test protocols, statistical data analysis, data verification, and
test reports for a technical audience including regulatory
agencies. Experience working independently to execute test
procedures and operate lab equipment (such as analytical balance,
tensile tester, and other automated test equipment) while
documenting results according to good documentation practices.
Familiarity with medical device engineering and applicable
standards, preferably ISO 11608-1, and their application. Day to
Day Responsibilities: This position includes three primary
responsibilities: (50%) Technical authorship of test protocols and
reports to support characterization and verification activities.
Technical documentation (Test Plans/Protocols/Reports, Engineering
Assessments, Design outputs, test-lab equipment/process/control)
(30%) Hands on execution of test protocols in a lab environment,
operating test equipment to collect data and record data according
to good documentation practices. Testing of autoinjector devices,
including the safe operation of test equipment (20%) Statistical
data analysis of test results to be included in technical reports.
Basic Qualifications: Master’s degree OR Bachelor’s degree and 2
years of experience OR Associate’s degree and 6 years of experience
OR High school diploma / GED and 8 years of experience Why is the
Position Open? Supplement additional workload on team. Red Flags:
Candidates with Software or Electrical engineering these are NOT
desired for the role. No lab experience Different industry No
mechanical or medical device experience. Spelling and grammatical
errors in resume. Frequent short job durations and job hopping.
Interview Process: Three to four one-on-one, 30 minute, remote
interviews with various team members. Able to start interviewing
immediately. 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, Lake Forest , Engineer, Medical Device Test Design and Execution (JP12062), Engineering , Thousand Oaks, California
