Principal IVD Engineer, Clinical Software

Overview

Waters is seeking a Principal IVD Software Engineer to help shape the future of our LCMS Clinical and Diagnostic software portfolio.

 

This is a highly influential individual contributor role suited to an experienced software engineer with deep expertise in regulated product development. You'll provide technical leadership across our LCMS Clinical Systems Development organisation, influencing architecture, engineering practices, technology strategy, and secure software development while helping to deliver innovative solutions that support clinical and diagnostic laboratories worldwide.

 

We are particularly interested in individuals who have contributed to the development of commercial IVD, healthcare, medical device, or other regulated software products and are passionate about applying those experiences to complex technical and organisational challenges.

About the Team

Clinical Systems Development is responsible for creating Waters' LCMS Clinical and In Vitro Diagnostic (IVD) systems, spanning both software and hardware. Our mission is to deliver meaningful customer benefits by evaluating, developing, and deploying innovative clinical technologies that improve laboratory workflows and support better healthcare outcomes.

Our teams bring together software engineers, scientists, systems engineers, quality specialists, and product leaders to solve complex interdisciplinary challenges. As a Principal Consulting Engineer, you'll contribute not only to technical solutions but also to the continued evolution of our engineering culture, capabilities, and ways of working.

What You'll Do

• Shape the technical direction of Waters' LCMS clinical and diagnostic software platforms.
• Bring insight and best practices from regulated product development to help strengthen engineering excellence.
• Influence architecture, technology strategy, engineering standards, and secure software development practices.
• Collaborate with multidisciplinary teams to solve complex technical and business challenges.
• Support the growth of engineers through mentoring, coaching, and technical leadership.
• Help advance software capabilities that enable innovative diagnostic and analytical solutions for laboratories worldwide.

Responsibilities

In this role, you will:

• Act as a senior technical authority for complex clinical and diagnostic software systems.
• Lead the evaluation and design of software architectures that balance performance, maintainability, scalability, security, and regulatory compliance.
• Guide engineering teams in adopting robust development practices, including software design, verification, validation, traceability, cybersecurity, and risk management.
• Partner with Software, Systems, Quality, Regulatory, Scientific, and Product Management teams throughout the product lifecycle.
• Contribute technical expertise to product planning, technology roadmaps, and architectural governance activities.
• Champion secure-by-design principles and help ensure cybersecurity considerations are incorporated throughout the software lifecycle.
• Evaluate emerging technologies, development approaches, industry trends, and evolving regulatory expectations to support future innovation.
• Influence technical decision-making across teams through collaboration, facilitation, and knowledge sharing.
• Support products from concept through release, sustainment, and post-market activities within regulated environments.

Qualifications

We are looking for engineers who enjoy solving complex problems, learning continuously, and creating technology that delivers meaningful value for customers and patients.

 

We value diverse experiences and perspectives. If your background doesn't align perfectly with every requirement but you believe you can succeed in the role, we encourage you to apply.

We'd Love to Hear From You If You Have

Essential

• Significant experience developing commercial software products in a Principal Engineer, Staff Engineer, Software Architect, Technical Lead, or comparable senior technical role.
• Demonstrated experience developing software products within regulated environments, ideally within IVD, healthcare, medical devices, diagnostics, life sciences, or related domains.
• Strong knowledge of software architecture, software design principles, and modern engineering practices.
• Experience working within regulated software development environments, including quality, safety, and cybersecurity considerations.
• Experience contributing to software verification, validation, requirements management, traceability, risk management, and software lifecycle activities.
• Ability to influence technical direction across multidisciplinary organisations through expertise, collaboration, and leadership.
• Strong communication skills with the ability to engage effectively with technical and non-technical stakeholders.

Desirable

• Experience supporting software products through regulatory submissions, inspections, audits, or product approvals.
• Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks.
• Familiarity with secure software development practices, vulnerability management, Software Bills of Materials (SBOMs), threat modelling, or secure-by-design principles.
• Experience with analytical instrumentation, laboratory informatics, clinical workflows, or LC/MS technologies.
• Experience introducing or scaling engineering best practices across teams or organisations.

Why Join Waters?

This role offers a unique opportunity to influence the future of clinical software within a global organisation at the intersection of healthcare, diagnostics, and analytical science.

You'll work alongside experts from multiple disciplines, contribute to products that support laboratories around the world, and help shape the technologies, architectures, engineering practices, and cybersecurity foundations that will underpin the next generation of clinical and diagnostic solutions.

For the right individual, this role provides the opportunity to have a lasting impact on products, people, and engineering culture while remaining hands-on with complex technical challenges.

Our Commitment to Inclusion

We're committed to building diverse teams and creating an environment where everyone feels respected, supported, and able to do their best work.

We believe innovation thrives when people bring different experiences, perspectives, and ways of thinking together. We welcome applications from candidates of all backgrounds and encourage those who may not meet every listed requirement to apply.

We're happy to discuss reasonable adjustments throughout the recruitment process and will do our best to support individual needs.

Please feel free to ask about hybrid working and flexibility during the recruitment process.