Device Engineer

Aptask Global Workforce (AGW) is seeking a Device Engineer for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity.

The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development, failure investigation, and continuous improvement initiatives. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of mechanical delivery devices are maintained.

Responsibilities:

• Adhere to strict documentation practices in a GMP regulated environment
• Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria
• Author and review technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques
• Coordinate and execute laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintain combination product design history files for assigned products
• Develop characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• Provide 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

Requirements:

• Bachelor's Degree in a relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering) with 2 years of experience, or Associate degree with 6 years of experience, or High school diploma / GED with 8 years of experience
• Experience in a GMP regulated environment
• Strong technical writing skills and ability to communicate technical topics
• Hands-on experience with in-lab testing
• Familiarity with Quality System Regulation (21
  
  CFR
  820), Risk Management (ISO 14971), and EU Medical Device requirements

Desired skills:

• Experience with Tolerance Stack-Ups (2D, 3D, RSS)
• Experience with Instron force tester using Blue Hill Universal
• Proficiency with Statistical Analysis software (Minitab or JMP)
• CAD fixturing software skills (Solid Works)
• Experience with design controls, including verification and design transfer
• Background in medical device development, commercialization and knowledge of manufacturing processes

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.