Staff Software Engineer

Pune, Maharashtra, India
Lead the adoption and practical application of AI-enabled software engineering practices for medical device software. The position focuses on spec-driven development, agentic development workflows, and enterprise-grade use of AI tools to improve software quality, productivity, traceability, risk management, cybersecurity, and delivery consistency within a formal software development lifecycle. The engineer acts as an AI champion by guiding teams in the effective and responsible use of tools such as GitHub Copilot, Microsoft 365 Copilot, Copilot Studio, and related AI-enabled development platforms. The role partners with software teams, product owners, quality, regulatory, cybersecurity, cloud engineering, and architecture stakeholders to ensure AI-assisted engineering practices align with medical device and regulated software expectations. The position is responsible for defining practical AI-assisted engineering workflows, establishing reusable specifications and development practices, evaluating emerging AI tools, and helping teams translate product, device, and cloud application needs into clear, traceable, and verifiable software artifacts.

• Leads AI adoption within the software organization by serving as an AI champion, coach, and technical change agent for medical device software development teams.
• Defines and promotes spec-driven development practices that connect requirements, architecture, design, implementation, testing, risk management, cybersecurity, and traceability.
• Designs and implements agentic development workflows that use AI agents to assist with requirements analysis, design generation, code development, test creation, review support, documentation, and compliance evidence generation.
• Establishes practical guidance for responsible and effective use of AI tools in embedded software development, including expectations for human review, technical accountability, security, privacy, and quality control.
• Champions the use of Microsoft and GitHub AI tools, including GitHub Copilot, Microsoft 365 Copilot, Copilot Studio, Azure AI Foundry, and related AI-assisted engineering capabilities.
• Works with software, quality, regulatory, cybersecurity, cloud engineering, and compliance stakeholders to ensure AI-assisted workflows align with formal software development processes and regulated medical device expectations.
• Develops reusable templates, prompts, specifications, acceptance criteria, workflows, and guidance for AI-assisted software development.
• Leads pilots, proofs of concept, and rollout plans for AI-enabled engineering practices across software teams developing medical device software and cloud applications.
• Evaluates emerging AI software engineering tools and recommends adoption strategies based on productivity, quality, cybersecurity, compliance, maintainability, and long-term supportability.
• Supports the development of software specifications, architecture inputs, design documentation, verification strategies, and traceability artifacts for device and cloud application software.
• Mentors engineers and technical leaders, on effective use of AI for design quality, test generation, documentation, software reviews, regulatory traceability and technical decision-making.
• Defines metrics and feedback mechanisms to measure AI adoption effectiveness, productivity gains, quality impact, test coverage improvement, documentation quality, and engineering process improvement.
• Applies knowledge of medical device software standards, software risk management, cybersecurity expectations, and controlled development processes when defining AI-enabled engineering workflows.
• Serves as a technical liaison with internal teams, technology partners, and vendors for AI-enabled development initiatives and related software engineering tools.

Bachelor's Degree in Engineering General

• Requires 10+ years of related software engineering, software architecture, embedded software development, or software process leadership experience.
• Bachelor’s degree in Computer Engineering, Software Engineering, Artificial Intelligence, Data Science, Biomedical Engineering, or equivalent degree required.
• Five or more years of experience in a technical leadership role within a software development organization.
• Experience developing software for medical devices, connected products, cloud applications, or another regulated industry requiring formal software development processes.
• Experience working within regulated software lifecycle expectations, including requirements management, software risk management, verification planning, design reviews, traceability, and controlled documentation.
• Demonstrated experience applying AI-assisted software development practices in a professional software organization.
• Experience serving as an AI champion, technical transformation leader, innovation lead, or productivity enablement leader within a software development organization.
• Experience developing software using spec-driven development, requirements-to-design workflows, test-driven or behavior-driven practices, and traceability-focused engineering approaches.
• Experience designing or implementing agentic development workflows, AI-assisted development pipelines, AI-enabled engineering productivity solutions, or automation workflows that improve software delivery.
• Experience with Microsoft and GitHub AI tools such as GitHub Copilot, Microsoft 365 Copilot, Copilot Studio, Azure AI Foundry, or similar enterprise AI platforms is preferred.
• Experience applying software engineering practices across embedded/device software and cloud-connected application environments is preferred.

• Knowledge of regulated medical device software development standards and practices, including IEC 62304, ISO 14971, design controls, software risk management, verification, validation, and traceability.
• Understanding of cloud application software development, cloud-connected product architectures, APIs, cybersecurity, data protection, DevOps practices, and operational support considerations.
• Experience translating product needs into clear specifications, architecture inputs, acceptance criteria, verification strategies, and traceable development artifacts.
• Understanding of secure and responsible AI use, including data protection, intellectual property considerations, cybersecurity risk, model/tool limitations, and human review expectations.
• Strong communication, coaching, facilitation, and stakeholder management skills.
• Experience leading and influencing cross-functional teams through technical change.
• Experience working in the medical device industry or another regulated industry that requires formal software development processes and software risk management is preferred.
• Travel up to 10%, including international travel

Serves in a software leadership role responsible for establishing AI-enabled engineering practices across multiple medical device software and cloud application projects or teams.
Reviews and guides AI-assisted development workflows, specifications, agent designs, prompt patterns, tool usage practices, adoption plans, and related engineering artifacts to ensure alignment with enterprise software development and regulated product expectations.
Provides technical direction on how spec-driven development, agentic development, and AI-assisted engineering tools should be applied within formal software lifecycle processes.
Influences long-term software engineering strategy by identifying practical opportunities to improve productivity, quality, traceability, cybersecurity, verification readiness, and development consistency through responsible AI adoption.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit .
STERIS strives to be an Equal Opportunity Employer.
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Join us as a Staff Software Engineer to design and architect software solutions for medical devices and IT applications. Lead teams in developing embedded software, oversee system architecture, and mentor junior engineers. Ideal for experienced professionals with a strong background in embedded software and technical leadership.