What are the responsibilities and job description for the Device Engineer position at Discover International?
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.
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