Device Engineer - Discover International : Job Details

Device Engineer (1-Year Contract) – Hybrid | Thousand Oaks, CA

*At least 2 years of Medical Device or regulated environment experience with Degree in the field of Mechanical or Biomedical REQUIRED*

As a Device Engineer, you'll play a pivotal role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes. This position focuses on hands-on testing, failure analysis, and statistical evaluation within a laboratory environment.

Key Responsibilities

• Conduct experimental testing to support failure investigations and root cause analysis.
• Develop and execute test procedures to evaluate device performance and functionality.
• Analyze test data and apply statistical tools to derive actionable insights.
• Lead testing efforts for design changes and validate proposed modifications.
• Support scale-up, global launch, and continuous improvement of drug delivery devices.
• Collaborate with contract manufacturers and suppliers to ensure device quality and compliance.
• Maintain robust design history files for mechanical and electro-mechanical devices.
• Enhance Amgen's delivery device platform to meet evolving product and regulatory requirements.

Day-to-Day Responsibilities

• Plan and conduct work requiring independent evaluation and adaptation of techniques.
• Generate and maintain design specifications, protocols, and reports.
• Execute design verification/validation, FMEA, and statistical process controls.
• Perform system-level root cause investigations and coordinate design improvements.
• Ensure technical records are maintained in design history files.
• Collaborate with internal teams and external partners to develop manufacturing specifications.
• Stay current with regulatory standards, including 21CFR820 and ISO 14971.

Ideal Candidate Profile

• Strong experience in laboratory testing, particularly with combination products or medical devices.
• Proficiency in statistical analysis and experimental methods.
• Proven ability to solve problems, implement design solutions, and manage projects.
• Familiarity with regulatory requirements for medical devices.
• Exceptional attention to detail and organizational skills.