Aptask Global Workforce (AGW) is seeking a Device Engineer - Onsite for a position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12 month contract opportunity. 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. The successful candidate will demonstrate strong technical judgment, attention to detail, and the ability to connect day-to-day execution with broader product quality and compliance objectives.
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
Requirements: - Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- 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
Desired skills: - 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: 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device Regulation 2017/745
Pay range: up to $47.34 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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