Senior Product Manager - SaMD (Hybrid)

📋 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