Device Engineer Job Newbury Park California USA,Engineering

Position: Device Engineer #26-12079
Location: Newbury Park

Duration: 12 months contract

Job Description:

The Device Engineer will support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment. This role combines hands-on laboratory execution with technical operations support and sustaining engineering activities for combination products from development through global launch.
The engineer will support mechanical drug delivery devices, including prefilled syringes, through laboratory testing, design verification support, failure investigations, design change assessments, and maintenance of Design History File (DHF) documentation and traceability records. A key aspect of the role is understanding how testing activities support user needs, product requirements, risk controls, and verification strategies within the design control process.
This position requires a candidate who is comfortable working directly in the laboratory while applying structured engineering and documentation practices in a regulated environment. The engineer will collaborate cross-functionally with scientists, engineers, quality, manufacturing, and operations partners to support product improvements, technical investigations, inspection readiness activities, and execution of key project deliverables.
The successful candidate will demonstrate strong technical judgment, attention to detail, and the ability to connect day-to-day execution with broader product quality, compliance, and development objectives.

Ideal Candidate:

The ideal candidate is a hands-on engineer with experience executing laboratory testing, troubleshooting technical issues, and working within regulated product development environments. They are detail-oriented, organized, and capable of producing high-quality technical documentation and reliable experimental results.
They understand how laboratory activities support broader design control objectives, including traceability, risk management, verification strategies, and product quality. This person is able to connect user needs, product requirements, and test outcomes within a structured development process.
The ideal candidate demonstrates strong ownership, sound engineering judgment, and effective collaboration skills. They are comfortable managing multiple priorities in a fast-paced environment and are proactive in using digital tools such as Smartsheet, electronic lab notebooks, data visualization tools, and AI-enabled productivity tools to improve coordination, workflow efficiency, documentation quality, and team communication.

Key Responsibilities:

Support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment.
Contribute to sustaining engineering activities for mechanical delivery devices, including prefilled syringes, with responsibility for DHF maintenance, traceability, lifecycle documentation, and product improvements.
Plan, coordinate, and execute laboratory testing for device characterization, verification, design transfer, fill-finish support, and technical investigations.
Develop, execute, and document test methods, protocols, technical assessments, and reports using sound engineering principles and GMP documentation practices.
Ensure testing activities are clearly linked to user needs, design inputs, product requirements, risk controls, specifications, and verification objectives.
Analyze and interpret experimental data using engineering judgment and statistical tools to support technical decisions, investigations, design changes, and specification assessments.
Support root cause analysis, failure investigations, deviations, nonconformances, risk assessments, and design or manufacturing change evaluations.
Partner with engineering, quality, manufacturing, operations, and scientific teams to support product enhancements, launch activities, inspection readiness, and cross-functional deliverables.
Contribute to continuous improvement efforts that strengthen lab efficiency, testing reliability, documentation quality, traceability, and project visibility.
Use tools such as Smartsheet, Excel, electronic lab…