Senior Systems Engineer

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

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.

Let’s do this! Let’s change the world! The Senior Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property and quality deliverables of a combination product (device/biologic combination) development program. This role leads the capture of user needs and translation into system requirements and is also responsible for the functional decomposition and allocation to subsystems.

The Senior Systems Engineer owns respective systems engineering deliverables and ensures that the quality targets are satisfied, identifies and communicates technical risks and coordinates risk retirement activities on the program. Also, maintains close cross-functional interaction within Amgen to deliver on customer satisfaction through high product quality. This AMA-based role requires regular collaboration during East Coast business hours and partners across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams to ensure lifecycle changes are assessed, documented, and implemented in a controlled manner.

Lead systems engineering assessment, planning, and cross-functional coordination of lifecycle change controls. Perform system-level impact assessments for proposed changes, including impacts to requirements, design documentation, risk management, traceability, verification evidence, and combination product configurations. Maintain system requirements, specifications, and traceability as released systems evolve. Determine and coordinate re-verification or additional verification when lifecycle changes could affect the verified state. Maintain systems engineering-owned design control documentation, including requirements, traceability, verification plans and reports, risk inputs, and change assessments.

Support supplier-, packaging-, labeling-, manufacturing-, and subsystem-driven changes that affect the combination product system. Lead systems engineering evaluation and implementation planning for new or revised standards and regulatory requirements. Support design transfer activities and implementation of approved lifecycle changes. Drive continuous improvement in lifecycle management processes, requirements practices, verification approaches, and reuse of engineering evidence. Communicate technical assessments, recommendations, risks, and implementation status to cross-functional stakeholders and leadership.

Lead requirements development and maintenance activities, including alignment of user needs, design inputs, design outputs, and verification and validation planning. Review and approve completed design documentation. Drive systems…