Engineer, Mechanical Device Laboratory Design and Testing Lifecycle (JP13662)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Mechanical Device Laboratory Design and
Testing (JP13662) Location: Thousand Oaks, Ca. Business Unit:
Prefilled Syringes And Lyo Kit Platforms Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate : $36-41/hours W2 with benefits Posting Date: 2/5/2025 Target
Start Date: 3/3/2025 3 Key Consulting is hiring! We are recruiting
an Engineer for a consulting engagement with our direct client, a
leading global biotechnology company. Ideal Candidate: Excellent
communication, force testing experience, design verification
testing (design controls), understanding of mechanical systems and
design, proficiency with MS suite. Bachelors in relevant
engineering or any scientific field as long as they have hands on
Laboratory Experience in a GxP Setting (Science or Engineering
Lab). Willing to consider those with relevant internship
experience. Job Description: The Device Engineer will participate
in the design, development, and lifecycle management of design
control activities for commercialized drug delivery devices. This
role includes technical operations support for combination product
development to global launch, clinical and commercial
manufacturing, failure investigation, design change evaluation,
development and execution of test procedures, and continuous
improvement initiatives. Scope includes mechanical delivery
devices, such as Prefilled syringes. The qualified candidate will
be part of a sustaining device engineering team that ensures design
history files of these mechanical delivery devices are maintained.
The engineer will participate in cross functional teams, leading
device design activities such as the development of product
enhancements, analytical failure analysis and implementation of
design solutions, assessment of proposed changes, support product
launches, defend inspection and ensure the follow through of
commitments. Essential skills and Responsibilities: Adheres to
strict documentation practices in a GMP regulated environment
Engineering competency in all conventional aspects of the subject
matter, functional area, and assignments Plans and performs work,
independently evaluating, selecting, and adapting standard methods,
and creating new solutions to engineering problems. Authors and
reviews technical documentation including protocols, reports, and
technical assessments Coordinates and executes laboratory testing
to support characterization, verification, design transfer, and
fill-finish efforts Analyze and trend generated data by applying
relevant statistical techniques to enable senior staff to make
informed decisions Maintains device and combination product design
history files for assigned products Ensure test methods and test
protocols are developed in a sound and robust framework with high
focus on eliminating test errors Provides functional subject matter
expertise to actively participate in cross-functional activities
including system level root cause analysis, design changes, and
change control assessments Provide general laboratory support
including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop
appropriate design and manufacturing specifications Preferred
Qualifications: Bachelor’s Degree or higher in relevant engineering
or scientific field (Mechanical, Biomedical, Bioengineering)
Understanding of Mechanical Design Engineering Concepts Experience
with Final Drug Product and/or Drug Product, medical device
development, commercialization and knowledge of manufacturing
processes (fill-finish) Experience with design controls; including
(but not limited to) design verification and transfer Understanding
of risk assessments including hazard and probability analysis
Experience with investigations and quality records Laboratory and
electronic lab notebook experience Statistical Analysis software
(Minitab or JMP) Experience with Instron force testers using
BlueHill Universal Test method development, GR&R, and text
fixture design Ability to work independently and dynamically across
functional teams Strong technical writing and verbal communication
skills including technical presentations (i.e., PowerPoint) Ability
to support complex workstreams under demanding timeline
Understanding of the following standards and regulations: Quality
System Regulation – 21CFR820; Quality Management System for medical
device/component manufacturers - ISO 13485 Risk Management for
Medical Devices – ISO 14971; EU Medical Device Regulation –
2017/745 Top Must Have Skill Sets: Hands on Laboratory Experience
(Science or Engineering Lab) Good Communication and Technical
Writing Skills Ability to Multitask Complex Workstreams Day to Day
Responsibilities: The device engineer will support a team of
engineers on a variety of projects related to laboratory testing,
device life cycle management, and product-based initiatives
regarding prefilled syringes in both commercial and developmental
space. The engineer will be expected to author protocols, reports,
and further technical documentation while adhering to GMP
standards. Laboratory testing will primarily include the use of an
Instron force tester and vision system. The identified candidate
must be able to lift up to 50 lbs for receipt and transferring of
material. Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of
supporting tasks for projects in a timely manner while maintaining
a high standard of quality. 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 Employee Value Proposition Unique industry opportunity
Networking Career growth Red Flags: 1. Remote work only 2. No
previous industry or laboratory experience 3. Unfamiliar with Good
Documentation Practices 4. Poor communication 5. No to little
technical writing experience Interview Process: Panel Interview –
MS Teams 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, Torrance , Engineer, Mechanical Device Laboratory Design and Testing Lifecycle (JP13662), Engineering , Thousand Oaks, California
