A senior technical leader is sought to guide the architecture, reliability, compliance, and lifecycle evolution of deployed IoMT products and platforms. This role will champion technical strategy and architectural decisions for the installed base portfolio. Key responsibilities include driving product enhancements, modernization, and complex customer issue investigations.

Collaborating with cross-functional teams such as Engineering, Product Management, Quality, Service, Regulatory, Cybersecurity, and Operations, this individual will ensure solutions are scalable, compliant, and meet business and customer needs. The position acts as a crucial technical authority for root cause analysis, risk assessments, design reviews, and change management, all while upholding Quality Management System (QMS) requirements and regulatory standards.

By merging deep systems thinking with robust technical expertise, this leader will foster continuous improvement, navigate teams through ambiguity, and deliver high-quality solutions. The aim is to enhance product performance, elevate customer satisfaction, and create lasting business value.

Lead the system architecture, design, and technical strategy for the installed product portfolio, prioritizing reliability, scalability, security, and regulatory compliance. Provide technical direction throughout the product lifecycle, encompassing enhancements, sustaining engineering, modernization, and technology refreshes.

Spearhead investigations into customer, field, quality, and cybersecurity issues, focusing on root cause analysis, impact assessment, corrective actions, and long-term solutions. Partner with Product Management, Engineering, Quality, Service, Regulatory, and Operations to translate needs into robust system designs.

Define and manage system requirements, architecture, interfaces, and traceability. Drive architectural reviews, technology evaluations, and design trade-offs. Ensure adherence to QMS, Design Controls, Risk Management, CAPA, and regulatory mandates. Mentor engineering teams on systems engineering best practices and advanced methodologies like AI-assisted development and automation.

A Bachelor's or Master's degree in Computer Science, Software Engineering, Systems Engineering, Biomedical Engineering, or another STEM field is required. Candidates must possess at least 10 years of overall industry experience in software, systems engineering, or product development. A minimum of 3 years of experience within MedTech or regulated product development environments is essential.

Demonstrated expertise in Systems Engineering, System Architecture, QMS, Design Controls, Risk Management, and Product Lifecycle Management is critical. Proven experience leading customer and field issue investigations, CAPA activities, change management, and cross-functional technical initiatives is also necessary.

Desired characteristics include expertise in CAPA, CCN, ECR/ECO, SCR, defect triage, risk reviews, and design change processes. Experience with connected healthcare systems, cloud platforms, EMR interoperability, communication protocols, and software verification is a plus. The ability to influence across organizations and lead without direct authority, coupled with excellent communication and stakeholder management skills, is highly valued.