Beckman Coulter Diagnostics is seeking a Chief Software Architect to lead innovative software development for medical devices and clinical diagnostics. This role involves overseeing complex software architecture, ensuring compliance with regulatory standards, and mentoring a high-performing team in a fast-paced environment focused on improving patient health globally.
Key Responsibilities
Lead the definition and execution of software architecture roadmaps
Define and maintain the overarching architecture for software platforms and products
Drive the design of a new digital platform and services
Apply software development methodologies appropriate for regulated medical software
Incorporate IEC 62304-compliant processes
Collaborate with cross-functional stakeholders to translate business requirements into software solutions
Oversee technical risk management activities and architectural reviews
Spearhead adoption of state-of-the-art software development tools
Support IP strategy and innovation
Build and mentor a high-performing team of global software architects
Required Qualifications
Proven experience leading architecture for complex software products in regulated environments
Strong knowledge of software design patterns, microservices architecture, APIs, data architecture, and cybersecurity principles
Deep understanding of risk-based software development and regulatory compliance including IEC 62304 and ISO 14971
Experience with AI/ML-enabled systems and interoperability standards
Demonstrated success in developing reliable, secure, and scalable software solutions
Exceptional communication, collaboration, and leadership skills
Bachelor’s degree in computer science, Software Engineering, or related field with 15+ years of experience in software product development
Preferred Qualifications
Direct experience in in-vitro diagnostics (IVD) instrument development
Familiarity with industry standards such as IEC 62304, ISO 13485, and FDA/CE regulations
Experience with Agile frameworks adapted for regulated environments