Medical Device Mechanical Engineer

Overview

The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs.

• A. Problem solving (engineering skillset)
• B. Organization (self-starter and project level management)
• C. Communication (experience communicating at different levels and to different groups)

Nice to have: 1-2 years of experience

The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of Amgen’s combination product portfolio.

• Conducting hands-on experimental testing to support failure investigations and root cause analysis.
• Developing, executing, and refining test procedures to evaluate device performance and functionality.
• Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
• Supporting design changes by leading testing efforts to assess and validate proposed modifications.
• Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
• Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
• Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
• Enhancing and expanding Amgen’s delivery device platform as needed to meet evolving product and regulatory requirements.

• Have strong laboratory testing experience, particularly with combination products and medical devices.
• Possess a solid foundation in experimental methods and data analysis.
• Be proficient in statistical tools and methodologies.
• Demonstrate experience in failure analysis and implementing design solutions.
• Have a proven ability to collaborate effectively within cross-functional teams.
• Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
• Show familiarity with regulatory and quality requirements for combination products and medical devices.

This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing Amgen’s portfolio of drug delivery devices.

• Master degree OR
• Bachelor degree and 2 years of experience OR
• Associate degree and 6 years of experience OR
• High school diploma / GED and 8 years of experience