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
