Senior Device Engineer

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** Career Category
** Engineering## ##
** Job Description
**** Join Amgen’s Mission of Serving Patients
** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
** Senior Device Engineer
**** What you will do
** Let’s do this! Let’s change the world!

The 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. 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.
** Essential Skills and Responsibilities
*** 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, exercising influence across 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…