Senior Manager, Hardware Engineer, OLYSENSE

Job Description

The Senior Hardware Engineering Manager, OLYSENSE Hub Platform leads the hardware engineering section responsible for evaluating, integrating, qualifying, sustaining, and evolving commercial off-the-shelf (COTS) computing platforms used as regulated medical device hardware platforms. The role is accountable for delivery of high-quality technical work packages across technology development, product development, production transfer, post-market engineering, and lifecycle management activities.

The Senior Hardware Engineering Manager, OLYSENSE Hub Platform shall ensure state-of-the-art technical excellence in medical-grade computing platform architecture, systems integration, supplier and OEM management, reliability engineering, hardware qualification, and lifecycle sustainment. Unlike a traditional electronics design leadership role, this position emphasizes hardware platform architecture, COTS platform integration, supplier management, reliability, manufacturability, serviceability, and cross-functional execution rather than custom PCB or circuit board design. The role combines people leadership with senior technical leadership and is expected to operate at the intersection of functional management, platform ownership, and hands-on technical problem solving

This position will report directly to the Director, Software Engineering Edge and will represent the hardware engineering function for the OLYSENSE Hub platform within the broader SCC Platform engineering organization. The role is accountable for building, mentoring, and maintaining a highly capable hardware platform and systems integration engineering team of approximately 5 to 6 engineers, while ensuring that assigned technical work packages are delivered on target with respect to quality, timing, cost, manufacturability, reliability, compliance, serviceability, and patient safety.

The Senior Hardware Engineering Manager, OLYSENSE Hub Platform is accountable to define and maintain the long-term hardware platform roadmap supporting cloud-connected and on-premises AI-enabled medical device applications. This includes technology refresh planning, component obsolescence mitigation, end-of-life strategies, supplier and OEM alignment, reliability improvement, lifecycle cost optimization, resource and budget planning, and alignment of hardware platform decisions with software, AI, systems, operations, quality, and regulatory priorities.

Job Duties

• Lead hardware engineering strategy and planning for the OLYSENSE Hub platform, including budget, capacity, resources, infrastructure, laboratory capabilities, external engineering support, prototype builds, test equipment, suppliers, and production transfer needs.
• Build, lead, mentor, and develop the Hardware Platform and Systems Integration Engineering team, ensuring effective resource utilization, technical capability development, performance management, and alignment with Olympus business and product objectives.
• Provide technical leadership and accountability for hardware engineering deliverables, including architecture, component selection, interface specifications, verification inputs, test plans, design documentation, manufacturing transfer, lifecycle records, and technical contributions to the Design History File.
• Own the OLYSENSE Hub hardware platform roadmap and lifecycle strategy, including technology refresh, scalability, component obsolescence, alternate sourcing, end-of-life planning, platform consolidation, upgrades, and long-term platform sustainability.
• Lead cross-functional product development, production transfer, and lifecycle sustainment, partnering with Software, AI, Systems Engineering, Product Management, Quality, Regulatory, Operations, Purchasing, Suppliers, Contract Manufacturers, Service, and external laboratories to ensure product readiness, compatibility, reliability, manufacturability, and serviceability.
• Drive hardware reliability and continuous improvement, using field performance, failure data, manufacturing metrics, supplier performance, customer feedback, complaints, CAPA, post-market surveillance, and service data to address issues, reduce service burden, and improve platform robustness. Lead post-market investigations, engineering changes, product enhancements, and sustaining activities.
• Define and maintain electrical safety and EMC compliance strategy for the OLYSENSE Hub platform, applying applicable standards including IEC 60601-1, IEC 60601-1-2, IEC 62368-1:2023, and regional requirements. Coordinate external laboratory testing, test configurations, acceptance criteria, issue resolution, and supporting technical documentation.
• Develop hardware engineering capabilities, infrastructure, and external partnerships, including laboratory and test capabilities, prototype configuration management, supplier/OEM relationships, contract manufacturing interfaces, external engineering partners, and test laboratories required to support development, qualification, production, troubleshooting, and lifecycle management.
• Ensure execution within the Olympus Quality Management System and drive engineering efficiency, including compliance with design control and change management requirements and standardization of components, interfaces, design reviews, test planning, supplier engagement, lifecycle documentation, and technical decision-making.

Job Qualifications

Required:

• Bachelor’s degree in Electrical Engineering, Computer Engineering, Systems Engineering, Computer Science, Biomedical Engineering, Medical Engineering, or a related technical discipline required. Master’s degree in Biomedical Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline preferred.
• Minimum of 10 years of experience in hardware engineering, embedded/industrial PC platforms, COTS computing, medical electrical equipment, or comparable regulated hardware development.
• Minimum of 5 years of engineering leadership or people management, including technical leadership, resource planning, mentoring, performance management, and talent development.
• Strong experience integrating COTS/embedded computing platforms into production products, including CPUs/GPUs, motherboards, PCIe, storage, networking, peripherals, video interfaces, firmware/drivers, and Windows-based environments.
• Experience supporting the full medical device lifecycle, from concept through commercialization, production, and post-market/sustaining engineering, within design control and QMS requirements.
• Experience with electrical safety and EMC compliance, including IEC 60601-1, IEC 60601-1-2, IEC 62368-1, CISPR 32, and coordination with external test laboratories.
• Strong experience troubleshooting complex hardware issues involving thermal performance, power, signal integrity, EMC, electrical safety, reliability, video paths, software/driver interactions, manufacturing quality, suppliers, and field performance.
• Hardware Architecture & Systems Integration: Ability to architect, integrate, qualify, and sustain COTS medical-grade computing platforms using requirements, interfaces, standards, design controls, and risk-based engineering.
• Embedded Computing & Hardware/Software Integration: Strong understanding of embedded/industrial PC architectures, Windows IoT/Windows-based systems, GPUs, capture/video interfaces, storage, networking, peripherals, firmware, drivers, and configuration management.
• Manufacturing & Supplier Management: Ability to lead design transfer, production readiness, manufacturing scale-up, configuration control, supplier/OEM/CM relationships, and resolution of quality and supply-chain issues.
• Technical Judgment & Decision Making: Ability to balance patient safety, quality, regulatory compliance, performance, cost, manufacturability, supply chain, serviceability, software compatibility, and lifecycle considerations.
• Cross-Functional Leadership & Communication: Ability to lead and align Software, AI, Systems Engineering, Quality, Regulatory, Manufacturing, Purchasing, Service, suppliers, OEMs, contract manufacturers, and external laboratories. Communicate complex technical issues effectively to technical and non-technical audiences.
• Resource Planning & Execution: Ability to prioritize work, manage capacity and budget inputs, plan engineering infrastructure and external support, identify bottlenecks, manage escalations, and execute effectively under schedule, supplier, technical, quality, and regulatory constraints.
• People Development & Technical Ownership: Ability to mentor engineers, build technical capability, establish clear ownership, and continuously improve engineering practices, documentation, test strategies, supplier engagement, and technical decision-making.