Senior Device Engineer

Lets do this. Lets change the world. In this vital role you will serve as a technical leader in the design, development, and lifecycle management of drug delivery devices (e.g., prefilled syringes, vial kits) used in Amgens combination products. This role provides advanced engineering expertise, leads complex investigations, drives crossfunctional alignment, and influences decisions impacting Amgens 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 workstreams, 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 System Regulation, ISO 14971 Risk Management, and design control processes.

• High school diploma / GED and 10 years of Engineering and/or Operations experience OR
• Associates degree and 8 years of Engineering and/or Operations experience OR
• Bachelors degree and 4 years of Engineering and/or Operations experience OR
• Masters degree and 2 years of Engineering and/or Operations experience OR
• Doctorate degree, * Degree in Mechanical, Biomedical, or related Engineering discipline.
• Extensive experience in medical device/combination product development, commercialization, and regulated manufacturing environments.
• Experience with products with ophthalmic indications.
• Experience with lifecycle management of commercialized medical devices or combination products.
• Proven ability to lead complex, cross-functional engineering programs from concept through launch.
• Deep expertise in design controls, applied statistics, reliability engineering, and advanced problem-solving methodologies.
• Strong verbal and written communication skills with the ability to tailor messaging at multiple organizational levels.
• Excellent communication and technical writing skill.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career., As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease., We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.