Where you come in
You will translate high-level product vision, user needs, and UI/UX designs into detailed, testable technical requirements for our medical devices and associated mobile applications (Android and iOS).
You will create and maintain comprehensive system and software requirements specifications (SRS), ensuring alignment with higher-level system requirements, architecture, and risk management frameworks.
You will strategically employ GenAI tools (e.g., Gemini) to generate, analyze, and manage complex system engineering documentation, traceability artifacts, and to support system-level analysis, ensuring optimal prompt engineering for high-quality outputs.
You will lead and manage requirements traceability and conduct thorough reviews using tools like Jama Connect, guaranteeing completeness, clarity, and consistency throughout the product lifecycle.
You will collaborate closely with software engineers, hardware engineers, and test engineers to develop comprehensive system and subsystem test strategies, plans, and test cases that validate all documented requirements.
You will generate and maintain verification trace matrices and master trace matrices to demonstrate end-to-end traceability from requirements to test cases.
You will champion the adoption of systems engineering best practices throughout the product development lifecycle, advocating for rigorous processes within the team and across departments, including the effective integration of GenAI tools.
You will mentor and guide other engineers in systems engineering principles and advanced tool usage.
What makes you successful
You have a deep understanding of systems engineering principles, BLE architecture, mobile application development for both Android and iOS platforms, and medical device development.
You are an expert in utilizing GenAI tools (e.g., Gemini) to significantly enhance the efficiency and quality of system engineering documentation, traceability, and analysis. You can guide others in the effective use of these tools.
You are proficient in writing clear, concise, and testable requirements following industry standards such as IEC 62304 and ISO 14971.
You have a strong understanding of the software and hardware development lifecycle and extensive experience using requirement management tools (e.g., Jama Connect) and software development tools like Jira, TestRail, and GitHub.
You are a strong communicator and collaborator, able to effectively convey complex technical information to both technical and non-technical audiences and influence decision-making.
You have a proven ability to influence and guide cross-functional teams in adopting systems engineering best practices.
You bring a proactive mindset and a passion for developing high-quality, user-centric medical devices and mobile applications that improve people's lives.
Typically requires a Bachelor’s degree in an engineering discipline and 8+ years of related experience, or an advanced degree with 5+ years of related experience.
Nice to haves
INCOSE Certified Systems Engineering Professional (CSEP) certification.
Experience with AI/ML concepts beyond documentation generation, and advanced prompt engineering techniques.
Proven track record of leading complex systems engineering projects from concept through to commercialization.
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