Principal IVD Engineer, Clinical Software

In this principal-level, individual-contributor role, you will shape Waters’ LCMS clinical and diagnostic software platforms and lead technical directions in regulated product development. You’ll influence architecture, engineering practices, and secure software delivery while collaborating with cross-functional teams to deliver solutions for laboratories worldwide. You’ll mentor engineers and advance capabilities that improve clinical workflows and healthcare outcomes. This role offers an opportunity to impact the engineering culture and governance of regulated software products.

• Serve as a senior technical authority for complex clinical and diagnostic software systems
• Lead evaluation and design of architectures balancing performance, maintainability, scalability, security, and regulatory compliance
• Guide teams in robust development practices including verification, validation, traceability, cybersecurity, and risk management
• Collaborate with Software, Systems, Quality, Regulatory, Scientific, and Product Management across the product lifecycle
• Contribute to product planning, technology roadmaps, and architectural governance
• Champion secure-by-design principles and ensure cybersecurity considerations throughout the software lifecycle
• Evaluate emerging technologies, development approaches, and regulatory expectations to enable future innovation
• Influence technical decisions across teams through collaboration and knowledge sharing
• Support products from concept through release, sustainment, and post-market activities in regulated environments

• Significant experience developing commercial software in senior technical roles (Principal/Staff/Architect/Technical Lead)
• Experience developing software in regulated environments (IVD/healthcare/medical devices)
• Strong knowledge of software architecture, design principles, and modern engineering practices
• Experience in software verification, validation, requirements management, traceability, risk management, and lifecycle activities
• Ability to influence technical direction across multidisciplinary organizations
• Strong communication skills with technical and non-technical stakeholders

• leadership
• mentoring
• collaboration
• software architecture and design
• regulated software development practices (quality, safety, cybersecurity)
• verification and validation, traceability, risk management