Meet the team:
Reporting to the SVP Engineering, Head of R&D, the Director of Product Systems & Integration will lead the organization responsible for hardware product ownership, hardware and physical transmitter systems engineering, software-hardware system integration, and product-level technical integration. This leader will bring together the roles, methods, and technical leadership needed to translate product intent into integrated, reliable, manufacturable, and commercially scalable medical devices.
The organization will operate across the product lifecycle, from early requirements and architecture through subsystem integration, design verification, clinical builds, manufacturing transfer, and commercialization. The Director will establish clear technical accountability, strengthen systems engineering and design-for-six-sigma discipline, and develop HPOs and systems leaders who can make effective cross-functional decisions and deliver predictable product outcomes.
Where you come in:
• You will lead the Product Systems & Integration organization, including Hardware Product Owners, hardware systems engineering
• You will establish clear product-level technical ownership, decision rights, and operating mechanisms across HPOs, systems engineers, system integrators, functional engineering teams, program leadership, Quality, Regulatory, and Operations
• You will own the effectiveness of hardware product requirements, system architecture, interface definition, requirements decomposition and allocation, and end-to-end traceability across the product lifecycle
• You will lead cross-functional technical integration across software, electrical, mechanical, firmware, sensor, algorithm, process development, verification, manufacturing, and supplier teams to ensure the software system and hardware system work together as an integrated product
• You will ensure product-level technical risks, system interactions, and critical tradeoffs involving performance, reliability, cost, schedule, manufacturability, and regulatory impact are identified early, resolved with appropriate rigor, and escalated when needed
• You will conduct critical reviews of system-level design decisions, negotiate design requirements and specifications across functions, and ensure technical tradeoffs are resolved with clear ownership and evidence-based rationale
• You will attract, develop, and retain high-performing technical hardware product leaders and systems engineers, creating clear expectations, career paths, succession plans, and opportunities for broader technical leadership
• You will build a scalable Product Systems & Integration operating model with consistent practices, metrics, governance, and lessons learned across new product development, platform evolution, and sustaining programs
• You will strengthen technical readiness for engineering and clinical builds, design reviews, verification and validation, phase exits, manufacturing transfer, regulatory submissions, and commercial launch
What makes you successful:
• You have demonstrated experience leading multidisciplinary engineering or systems organizations that deliver complex, safety-critical, regulated products from concept through commercialization
• You bring strong systems engineering depth in product requirements, architecture, interfaces, integration, technical risk management, verification strategy, and design controls
• You bring practical design-for-six-sigma experience and can use structured engineering methods to improve product robustness, requirements quality, verification strategy, and manufacturing readiness
• You have the technical breadth to guide decisions across hardware, firmware, sensors, algorithms, mechanical systems, manufacturing processes, and connected product interfaces
• You bring experience in medical devices or another highly regulated industry; experience with connected wearable products, high-volume manufacturing, reliability engineering, or transmitter systems is…