Senior Project Systems Engineer (W2)

Responsibilities:

• Requirements & Traceability : Solicit, manage, and document stakeholder needs and requirements across constituent systems; perform requirements analysis, development, allocation, and management; create and maintain traceability from requirements (including system risk) to system verification and validation; manage requirements flow-down and interface requirements between constituent systems.
• Integration & Verification: Develop and document system test strategies; lead system integration, verification, and validation activities across constituent systems; participate in design reviews and contribute SE deliverables aligned with regulations and standards.
• System Design & Architecture: Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions; apply systems thinking to understand how constituent systems interact within the broader product ecosystem; define and manage system boundaries and interfaces between constituent systems.
• Risk Management: Support system-level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations; drive continuous process improvement focused on SE-related processes and tools; proactively identify and communicate quality issues.

Requirements:

• Bachelor’s degree in an engineering field with 5 years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities
• Qualified candidates must be legally authorized to be employed in the United States