Where you come in
You will independently develop, analyze, and manage system and subsystem requirements (including software and hardware) from user needs and product vision, ensuring clarity, testability, and completeness.
You will expertly leverage GenAI tools (e.g., Gemini) to generate, refine, and manage comprehensive system engineering documentation (SRS, design specifications) and complex traceability matrices, ensuring the integrity and accuracy of AI-assisted outputs.
You will define and implement strategies for requirements traceability using tools like Jama Connect, ensuring end-to-end linkage from user needs to verification.
You will collaborate with cross-functional teams (Software, Hardware, Test, Quality, UI/UX) to develop robust test plans and test cases, and oversee verification activities.
You will contribute to risk management activities (e.g., FMEAs) in accordance with ISO 14971 and other relevant standards.
You will mentor junior engineers and promote systems engineering best practices within the team.
You will actively participate in design reviews and technical discussions, providing valuable systems-level insights.
What makes you successful
You have a strong foundation in systems engineering principles and practices, with proven experience in requirements engineering, V&V, and system integration for complex products.
You are highly proficient in utilizing GenAI tools (e.g., Gemini) for advanced documentation generation, requirements analysis, and traceability management, with an ability to develop effective prompts and critically evaluate AI-generated content.
You possess excellent analytical, problem-solving, and technical writing skills, capable of translating complex concepts into clear, concise documentation.
You are proficient with requirements management tools (e.g., Jama Connect), and familiar with ALM tools (e.g., Jira, TestRail, GitHub).
You have experience working under medical device regulations (e.g., FDA QSR, ISO 13485) and standards such as IEC 62304 and ISO 14971.
You are an excellent communicator and collaborator, able to work effectively with diverse, cross-functional teams.
Typically requires a Bachelor’s degree in an engineering discipline and 5+ years of related experience, or an advanced degree with 3+ years of related experience.
Nice to haves
INCOSE Associate or Certified Systems Engineering Professional (ASEP/CSEP) certification or any Requirements Engineer certification.
Experience with mobile application development (Android/iOS) and/or BLE architecture.
Experience leading small project teams or technical initiatives.
Advanced prompt engineering skills for GenAI tools.
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