Principal Product Use And Performance Lead

Principal Product Use And Performance Lead

We are seeking a clinically oriented, data-driven Product Use & Performance Lead to join our Quality organization and lead the integration of product performance insights across the Pulse Field Ablation (PFA) portfolio. This unique role is not a traditional Design Quality Engineering position. Instead, it serves as a strategic, cross-functional partner who will synthesize clinical data, risk documentation, real-world use, and voice of customer into a cohesive understanding of product performance. This person will also serve as a key resource during high-visibility product discussions involving complex use scenarios or unexpected outcomes, helping ensure aligned and credible messaging.

Key responsibilities include:

• Serve as the Subject Matter Expert (SME) for clinical performance of PFA devices, ensuring an integrated understanding of safety, efficacy, and clinical use
• Author clear, evidence-based reports on key risks and emerging outcomes drawing from internal and external data
• Support cross-functional messaging during high visibility product situations by offering a clinically informed and risk-aligned narrative
• Coordinate across divisions and product lines to align performance views on products used in combination with PFA (Transeptal products, imaging, etc.)
• Attend EP procedures and collaborate with field teams to observe device use, identify workflow patterns, and gather insights from real-world use
• Provide internal training and guidance on procedural workflows, product use, and clinical context

What we're looking for in you: Minimal requirements:

• Bachelor's degree in Engineering, Life Sciences, Nursing, or a related clinical or technical field
• 7+ years in medical devices (clinical affairs, post-market surveillance, R&D, or product quality or other related), preferably within electrophysiology or ablation therapies
• In-depth knowledge of EP clinical workflows and procedural environments
• Strong communication and data synthesis skills

Preferred qualifications:

• Familiarity with risk management (ISO 14971) and Medical Device regulations (ISO 13485 and 21 CFR)
• Experience working across cross-functional teams, with a track record of influence without direct authority