Engineer, Drug Delivery Device / Lab Testing & Troubleshooting – Biotech (JP15413)

3 Key Consulting•Thousand Oaks, CA

34d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related engineering or scientific discipline.
Experience working in a regulated laboratory, medical device, pharmaceutical, biotechnology, or combination product environment.
Ability to independently plan, execute, document, and evaluate technical work using sound engineering or scientific principles.
Experience supporting laboratory testing, technical assessments, investigations, or product development activities.
Experience authoring or reviewing technical documentation in a regulated environment, such as protocols, reports, assessments, or investigation summaries.
Strong organizational skills with the ability to manage multiple priorities, maintain accurate records, and follow through on commitments.
Effective written and verbal communication skills with the ability to collaborate across technical and cross-functional teams.
Hands-on device testing and lab execution
Experience working in a regulated design control environment
Strong technical documentation, data analysis, and digital tool skills

Nice To Haves

Bachelor’s degree or higher in a relevant engineering or scientific field
Experience with medical device, combination product, or regulated product development, particularly within a design control environment.
Familiarity with design controls and traceability across user needs, design inputs, product requirements, risk controls, specifications, and verification/validation activities.
Understanding of how intended use, user needs, and risk management inform testing strategies, requirements, and design decisions.
Experience supporting Design History File documentation, traceability matrices, design verification, design changes, or lifecycle management activities.
Hands-on laboratory experience with device characterization, test method development, fixture design, GR&R, or mechanical testing.
Experience with Instron force testers, BlueHill Universal, electronic lab notebooks, and statistical analysis tools such as Minitab or JMP.
Experience supporting investigations, deviations, nonconformances, root cause analysis, risk assessments, or change control records.
Experience using digital tools such as Smartsheet, Excel, data visualization tools, electronic lab notebooks, or AI-enabled productivity tools to improve project tracking, workflow efficiency, documentation quality, and team communication.
Strong technical writing, presentation, and stakeholder communication skills.
Ability to work independently and collaboratively across dynamic, cross-functional teams while supporting complex workstreams under demanding timelines.
Understanding of applicable regulations and standards, including: o 21 CFR 820 – Quality System Regulation o ISO 13485 – Quality Management Systems for Medical Devices o ISO 14971 – Risk Management for Medical Devices o EU Medical Device Regulation 2017/745

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 notebooks, data analysis platforms, and AI-enabled productivity tools to improve project coordination, workflow management, communication, and operational efficiency.