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

Job Title: Engineer, Drug Delivery Device / Lab Testing & Troubleshooting – Biotech (JP15413)
Location: Thousand Oaks, CA
Employment Type: Contract
Business Unit: PFS & Kit Platform
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $43 - $47/hour W2
Target Start Date: 6/8/2026
Notes: Fully onsite

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

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

Basic Qualifications

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.

Preferred Qualifications:

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

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Hands-on device testing and lab execution
Experience working in a regulated design control environment
Strong technical documentation, data analysis, and digital tool skills

Day to Day Responsibilities:

Execute hands-on laboratory testing and device evaluations.
Analyze and document technical data, results, and observations.
Troubleshoot issues and support investigations, root cause analysis, and design changes.
Maintain documentation and traceability within a regulated design control environment.
Collaborate with cross-functional teams to support product improvements and project execution.
Use digital tools to manage data, documentation, workflows, and communication.

Red Flags:
-Little to no hands-on experience
-Weak design control or documentation discipline
-Lack of organization, digital skills, or process-improvement mindset

Interview process:
1:1 Virtual (via Microsoft Teams) Interview with Hiring manager, with potential to proceed to virtual group panel.

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.