3 Key Consulting, Inc. · 4 months ago
Engineer – Combination Device Design, Development & LCM (JP14435)
Thousand Oaks, CA
Full-time
Onsite
Entry, Mid Level
$36/hr - $41/hr
2+ years exp3 Key Consulting, Inc. is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The Device Engineer will participate in the design, development, and lifecycle management of drug delivery devices, providing technical operations support for product development, manufacturing, and continuous improvement initiatives.
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Responsibilities
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the 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 systems
The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material
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
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
Qualification
Required
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
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
Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
Good Communication and Technical Writing Skills
Statistical Analysis
Preferred
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
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase