Engineer, Combination Product Medical Devices - (JP14307)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Combination Devices Medical Device
(JP14307) Location: Thousand Oaks, CA. 91320 Employment Type:
Contract Business Unit: Final Product Technologies/Development
Product Engineering Duration: 1 years (with likely extensions
and/or conversion to permanent) Posting Date: 07/15/25 Pay Rate:
$36 - $41/hour W2 Notes: Only qualified candidates need apply.
Recent college graduates welcome 3 Key Consulting is hiring an
Engineer for a consulting engagement with our direct client, a
leading global biopharmaceutical company. Job Description: This
position reports into the Combination Product Operations
Development and Lifecyle Management group in Thousand Oaks, CA. The
candidate will support senior staff in device development,
characterization, and verification of combination products. This
position requires the application of engineering principles to
perform the job functions and the ability to coordinate and
communicate effectively across different functions to successfully
complete projects. In this role, the candidate will be required to:
Plan and author technical documentation, including test
plans/protocols/reports and a variety of engineering assessments.
Perform hands on testing of autoinjector devices, including the
safe operation of test equipment and devices containing sharps
(syringes). Analyze and report data, along with any
recommendations, to a variety of stakeholders. Provide technical
input for mechanical problems to programs as needed. Plan and
execute tolerance and robustness analysis of complex mechanical
designs. Use project planning to monitor and track project
deliverables to ensure accurate completion. Collaborate with
cross-functional teams to ensure adequate sustainment and
improvement of products throughout their lifecycle. As part of the
team working on device platforms, ensure alignment of documentation
to support variants and combination products. Why is the Position
Open? Additional hands for project Top Must Have Skills: Strong
written and oral communication skills Able to execute lab test,
which includes safe and proper operation of lab equipment
Experience in drug/device combination product design, and
development Day to Day Responsibilities: Planning and executing
testing, Coordinate material hand-offs, Authoring, reviewing and
approving documents, attending and participating in the team
meetings (as needed) 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 B.S. in Engineering or Scientific Discipline Effective
Communicator (Oral/Written) Technical Writing (Protocols, Reports,
Technical Assessments, Presentations) Preferred Qualifications:
Broad set of knowledge and expertise in contributing to complex,
multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design, and
development Background in development, commercialization, and
lifecycle management of medical devices Physical test method
development, qualification, and validation Experience executing lab
tests, including safe and proper operation of lab equipment
(Instron tensile tester, Keyence inspection equipment, manual and
automated autoinjector testing, CT scanner etc.) Experience
conceptualizing, designing, and building test fixtures Technical
understanding of drawings including tolerance stacks and robustness
analysis Knowledge of Quality Management System, Quality Management
Policy and applicable laws and regulations as they apply to this
job type/position Familiarity with the following standards: US Good
Manufacturing Practices (21CFR820), Quality Management (ISO 13485),
Risk Management (ISO 14971), EU Medical Device requirements
(Council Directive 93/42/EEC), Needle Based Injection Systems (EN
ISO 11608-1), and Medical Electrical Equipment (EN 60601) Knowledge
of dFMEA/pFMEA Capable of working on multiple projects in a
deadline driven environment Strong oral and written communication
skills, decision making, presentation, and organization skills
Ability to collaborate with other disclines within the technical
team such as, systems engineering, design engineering, human
factors, MSAT, packaging engineering and other functions e.g., drug
product, drug substance and product quality. Demonstrate ability to
navigate ambiguity and provide a structured problem-solving
approach Track record of building or participating as a member of
successful teams Working knowledge of MS Office tools, Solidworks,
Minitab or JMP and Smartsheet Employee Value Proposition: Gaining
combination product development experience and a better sense of
device performance. Will gain auto injector experience Interview
process: Phone interview(s). 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, Fountain Valley , Engineer, Combination Product Medical Devices - (JP14307), Engineering , Thousand Oaks, California
