Senior Systems Engineer
About The Position
The Senior Systems Engineer leads systems engineering activities within a cross-functional program team developing combination products (device/biologic combinations). The role develops technical content, performance, intellectual property, and quality deliverables; captures user needs and translates them into system requirements; and decomposes and allocates requirements to subsystems. The engineer owns systems engineering deliverables, helps ensure quality targets are met, identifies and communicates technical risks, and coordinates risk retirement activities while working across Amgen functions to support customer satisfaction and product quality. This AMA-based role requires regular collaboration during East Coast business hours with engineering, quality, regulatory, supply chain, packaging, labeling, and product teams. It leads lifecycle change-control assessment and coordination, evaluates system-level impacts of proposed changes, maintains requirements and traceability as released systems evolve, and determines when re-verification is needed. The role maintains design-control documentation, supports design transfer and approved changes, assesses new or revised standards and regulatory requirements, and drives continuous improvement in lifecycle management, requirements practices, verification approaches, and reuse of engineering evidence. It also leads requirements development and maintenance, reviews and approves design documentation, contributes to design reviews, resolves system-level technical issues, and mentors junior engineers.
Requirements
- Doctorate degree; or a master's degree and 2 years of experience; or a bachelor's degree and 4 years of experience; or an associate's degree and 8 years of experience; or a 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 product development experience working with mechanical medical devices; combination product experience is preferred.
- 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 documenting technical rationale and presenting 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.
- Ability to collaborate regularly during East Coast business hours.
- Ability to mentor junior engineers.
Nice To Haves
- Formal Systems Engineering training or certification.
- Demonstrated applied Lean Six Sigma competency.
- Experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination).
- Creative problem-solving and solution-development ability when faced with conflicting requirements, business demands, and technical risks or issues.
Responsibilities
- Lead development activities within a cross-functional program team for combination product development.
- Capture user needs and translate them into system requirements; perform functional decomposition and allocate requirements to subsystems.
- Own systems engineering deliverables and ensure quality targets are satisfied; identify and communicate technical risks and coordinate risk retirement activities.
- Lead systems engineering assessment, planning, and cross-functional coordination of lifecycle change controls.
- Perform system-level impact assessments of 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, aligning 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.
- Collaborate regularly during East Coast business hours with engineering, quality, regulatory, supply chain, packaging, labeling, and product teams.
Benefits
- Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents.
- Retirement and Savings Plan with generous company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
- Work/life balance support.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
