Senior Device Engineer - Thousand Oaks, CA

Overview

Senior Device Engineer  Senior Device Engineer serves as a technical leader in the design, development, and lifecycle management of drug delivery devices (e.g., prefilled syringes, vial kits) used in Amgen’s combination products. This role provides advanced engineering expertise, leads complex investigations, drives cross-functional alignment, and influences decisions impacting Amgen’s strategic product portfolio. It ensures that design history files for devices are robust, compliant, and positioned for long-term sustainability.

It also aims to enhance the prefilled syringe and kit platform, evaluates and implements design changes, develops technical standards, contributes to global product strategy and launches, and acts as a technical mentor to peers and junior engineers while representing the device engineering function across the Amgen network.

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The Senior Device Engineer serves as a technical leader in the design, development, and lifecycle management of drug delivery devices used in Amgen’s combination products. This role provides advanced engineering expertise, leads complex investigations, drives cross-functional alignment, and influences decisions impacting Amgen’s strategic product portfolio. This role is accountable for ensuring that associated design history files for devices are robust, compliant, and strategically positioned for long-term sustainability.

This role also seeks to enhance capabilities of the prefilled syringe and kit platform, evaluates and implements design changes as necessary, develops and strengthens technical standards, contributes to global product strategy and launches, and will act as a technical mentor to peers and junior engineers while representing the device engineering function across the broader Amgen network.

• Functions as a fully competent and highly independent subject-matter expert, applying advanced engineering judgment to evaluate, adapt, and create methodologies that solve complex technical challenges.
• Leads design and development efforts, influencing technical direction and ensuring alignment with prefilled syringe and vial kit platform strategy as well as regulatory expectations.
• Hosts and facilitates design reviews and assessments, both during development as well as post-launch for commercialized devices.
• Serves as a technical reviewer and approver for design documentation, analyses, and verification/validation packages.
• Directs system-level root cause investigations with cross-functional stakeholders, ensuring robust technical justification and durable corrective actions.
• Uses statistical tools, modeling, and risk-based frameworks to diagnose issues and develop data-driven solutions.
• Oversees creation and maintenance of design specifications, technical standards, protocols, test methods, and comprehensive engineering reports.
• Leads design verification and validation work streams, FMEA leadership, and statistical process control efforts where applicable.
• Ensures technical records meet global regulatory expectations and withstand inspection scrutiny.
• Acts as a key technical representative within networked project teams, influencing functions such as Product Quality, Regulatory, Process Development, Supply Chain, and external partners.
• Drives design improvements with development partners, contract manufacturers, and suppliers by integrating feedback, capability assessments, and manufacturability strategies.
• Contributes to long-term technology roadmaps and platform expansion efforts.
• Leads design changes, post-launch investigations, product optimizations, and scale-up activities.
• Supports and defends regulatory submissions, inspections, and commitments at a senior level.
• Serves as a technical mentor and coach to other core and extended team members.
• Demonstrates advanced working proficiency in 21 CFR 820 Quality System Regulation, ISO 14971 Risk Management, and design control processes.

• Auto req 464477
• Minimum Education Required High School/GED

• High school diploma / GED and 10 years of Engineering and/or Operations experience OR
• Ass…