Senior Systems Engineer
Amgen
Summary
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.
Job description
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.
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 engineering input to design reviews and facilitate cross-functional resolution of system-level technical issues.
- Mentor Junior engineers.
Requirements
- Doctorate degree OR Master’s degree and 2 years of experience OR Bachelor’s degree and 4 years of experience OR Associate’s degree and 8 years of experience OR High school diploma / GED and 10 years of experience
- 6+ years of progressive experience as an engineer within the appropriate field of study
- 5+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination)
- Formal Systems Engineering training/certification
- Demonstrated applied lean 6 Sigma competency
- Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
- Demonstrated experience in systems engineering, product development, medical devices, or combination products
- Strong lifecycle management and change-control experience in a regulated environment
- Strong understanding of design controls, requirements management, traceability, risk management, and design verification
- Experience conducting technically rigorous system-level impact assessments and defining verification needs for product changes
- Ability to lead assessment of new and revised standards and regulatory requirements and translate them into actionable engineering plans
- Proven cross-functional coordination and influence skills across technical, quality, regulatory, and operational functions
- Excellent written and verbal communication skills, including the ability to clearly document technical rationale and present complex information to diverse stakeholders
- Experience translating stakeholder and user needs into clear, testable system requirements and maintaining end-to-end traceability
- Working knowledge of system integration, interface management, design reviews, and verification and validation planning
- Ability to lead technical discussions, evaluate tradeoffs, and resolve cross-functional system-level issues
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Paid Time-off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.