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Job Description
📋 Description End-to-End Product Ownership: manage requirements from concept to launch. AI Integration: work with AI/ML and data science to add AI features. Regulatory & Compliance: ensure FDA/global regulatory alignment for SaMD. Neurodiagnostics: lead EEG-focused products for critical care. Release & Lifecycle: own release planning across design, dev, verification, and launch. 🎯 Requirements Bachelor’s in science/engineering; MBA/MS/PhD preferred; 7+ years in medical device software product dev. 3+ years consulting experience; device sales experience a plus. AI & Neurodiagnostics: strong medical device software/hardware background; AI-driven dev a plus. Regulatory: FDA 510(K) and 21 CFR 820.30 design controls; ownership of deliverables. Requirements Discipline: decompose complex clinical workflows into clear, testable requirements. Market Insight & Travel: conduct market research and travel up to 25%. 🎁 Benefits Performance-based incentive compensation Equity opportunities 100% employer-paid health benefits for employees 50-70% employer-paid health, dental & vision for dependents 401(k) with generous company match Employee Stock Purchase Plan (ESPP) with discount
