Engineer, Medical Combination Devices (JP11777)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Medical Combination Devices (JP11777)
Location: Thousand Oaks, CA. 91320 Business Unit: Combination
Product Development Employment Type: Contract Duration: 1 years
(with possible extensions) Rate : $38 - $42/hour W2 Posting Date:
09/18/2023 Notes: Only qualified candidates need apply. Local
candidates only. Should be standard hours Monday to Friday in
Office to support Denmark 2 times a week may be expected to be on
call at 6 am. can be done remote, but would come to site after
call. 3 Key Consulting is recruiting an Engineer for a consulting
engagement with our direct client, a leading global biotechnology
company. Job Description: Note: Not interested in remote only
candidates. Should be standard hours Monday to Friday in Office to
support Denmark 2 times a week may be expected to be on call at 6
AM PST. Can be done remote, but would come to site after call. Time
on campus will be lab work and will be working with lab equipment.
There is hybrid opportunity once candidate is seen to be
self-sufficient. Ideal candidate, Familiarity with medical device
engineering and applicable standards, preferably ISO 11608-1, and
their application. 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. 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: (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 (not
exp of med device). No mechanical or med device. 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, Rancho Palos Verdes , Engineer, Medical Combination Devices (JP11777), Engineering , Thousand Oaks, California
