Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Needle-Based Injection Systems Mechanical
Testing (JP13883) Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Design & Development ME Employment Type: Contract
Duration: 1 year with likely extensions and/or conversion to a
permanent position. Rate: $38 - $42/hour W2 Posting Date:
03/31/2025. Notes: Only qualified candidates need apply. Hybrid.
Must be local to Thousand Oaks, CA. Minimum 70% onsite after
training period. 100% onsite for training in the beginning. 3Key
Consulting is hiring! We are recruiting an Engineer - Needle-Based
Injection Systems Mechanical Testing - for a consulting engagement
with our direct client, a leading global biotechnology company. Job
Description: Our ideal candidate will have familiarity with medical
device engineering and applicable standards, preferably ISO
11608-1, and their application. (ISO 11608-1 Requirements and test
methods for needle-based injection systems (NIS) for medical use.
These systems are commonly used for the delivery of medicinal
products, such as insulin pens, auto-injectors, and similar
devices). 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 technical writing, reading
comprehension, 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. 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. • Nice to have: Background in statistical
analysis. Day to Day Responsibilities: • (50%) 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 • (35%) 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) • (15%) Statistical data analysis of
test results to be included in technical reports. 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: Red Flags: • Candidates with Software or Electrical
engineering these are NOT desired for the role. • No lab experience
• Different industry (no experience of med device) • No mechanical
or med device. • Spelling and grammatical errors in resume.
Frequent short job durations and job hopping. Why is the Position
Open? Supplement additional workload on team Interview Process:
There will be between 1-2 panel interviews, then final interview
with director.up interviews with Engineering staff. Once narrowed
down, a final interview with Associate Director of the team. 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, Irvine , Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883), Engineering , Thousand Oaks, California
