Engineer, Combination Device MS&T (JP13077t)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Engineer, Combination Device MS&T (JP13077t)
Location: Thousand Oaks, CA. 91320 Business Unit: Physical Methods
Development Modelling and Emerging Methods Employment Type:
Contract Duration: 2 years with likely extensions and/or conversion
to hire. Rate : $38 - $42/hour W2 Posting Date: 7/24/2024. Notes:
Only qualified candidates need apply. Can be within commutable
distance of client’s Thousand Oaks, CA. facility. 3 Key Consulting
is hiring! We are recruiting an Engineer, Combination Device
MS&T for a consulting engagement with our direct client, a
leading global biotechnology company. Job Description: Our ideal
candidate will have: 3 YOE in field desired with bachelors.
Experience working in a regulated industry, exposure to GMPs,
Medical Device experience is highly desired. Mathematical
background fundamentals of statistics. Useful to have exposure to
test method development, CAD design, SolidWorks, mechanical
modeling. Nice to have programming R and python experience. hands
on technical experience useful, comfortable working within a lab.
Position involves support of senior staff in the initiation,
design, and delivery of projects, particularly for the Combination
Product Operations MS&T - Physical Sciences and Engineering
(PSE) organization. Responsibilities include development and
lifecycle management of Physical GMP Test Methods, lifecycle
management of integrated testing machines, development and
validation of test methods. The successful candidate employs basic
engineering skills and practices to gather user requirements and
translate them into technical documentation. Assist with project
definition by performing engineering studies and assessment for
automated test systems installations. Perform field evaluations of
existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at
organizing information from numerous sources to provide
well-constructed deliverables. This individual has a passion for
modeling, analytics, and technology. The successful candidate will
be given opportunities to apply their expertise to enhance the way
data is used to inform and make decisions This may include, but is
not limited to, the following: Collaborate with Engineers using the
system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation
of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment
characterization protocols, Gauge Repeatability and Reproducibility
studies Assisting Engineers to successfully develop, transfer and
execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data Network
with manufacturing and quality organizations internal to client.
Ensuring all tasks and responsibilities are performed according to
industry-leading scientific standards & accurately documented per
SOPs Monitoring technological developments in the field &
evaluation of new technologies Top Must Have Skill Sets: Excellent
verbal and written communication skills to communicate project
status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics Ability to
manage multiple, competing priorities simultaneously Day to Day
Responsibilities: Collaborate with Engineers using the system to
edit, develop, and run automated, experimental protocols. Run Gauge
Repeatability and Reproducibility studies Assisting Engineers to
successfully develop, transfer and execute processes on the
integrated platforms and equipment. 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 Skills: Experience working in a
regulated industry, exposure to GMPs Excellent verbal and written
communication skills to communicate project status and risks
associated with integrated timelines to leadership Statistical
analysis, and knowledge of Gage R&R, Knowledge of Optical
measurement devices, force testers, BLE testing Test method
development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ Preferred Traits: Passion
for proactively identifying opportunities through creative data
analysis and modeling Intellectual curiosity with ability to learn
new concepts/frameworks, algorithms, and technology rapidly as
needs arise Ability to manage multiple, competing priorities
simultaneously, experience with MS Project Why is the Position
Open? Supplement additional workload on team Interview Process:
Phone screen. Panel 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, Laguna Beach , Engineer, Combination Device MS&T (JP13077t), Engineering , Thousand Oaks, California
