Software Development Process Engineer​/Specialist; Medical Device

Position: Software Development Process Engineer / Specialist (Medical Device)
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Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

At Varian, a Siemens Healthineers company, we are committed to creating a “World Without Fear of Cancer”. As part of the PTP (Processes, Technology, and Performance) – Processes Team, this role will play a critical part in shaping how software products for medical devices are developed, documented, and continuously improved across a global organization.

This position focuses on process development, governance, and continuous improvement for software design and development lifecycle activities. The role partners with global product development teams to ensure processes are efficient, compliant, and aligned with regulatory standards, while also advancing modernization initiatives such as digitalization and AI-enabled process innovation.

Key Responsibilities Process Development & Governance Author, update, and maintain procedures and work instructions supporting software design and development processes.

Ensure processes support controlled, planned, and documented software development across the full product lifecycle (concept through support).Align process documentation with key design control elements, software safety and cybersecurity considerations.

Support organizational readiness for audits and regulatory inspections by ensuring documentation and processes are complete and traceable.

Software Development Lifecycle (SDLC) Support Partner with engineering and product teams to ensure processes support lifecycle phases (Concept and planning, Iterative development, Verification and validation, Release and design transfer).Support process alignment with agile practices (Iterative development cycles, Backlog management and user stories, Definition of Done (DoD) and release readiness).Collaborate with global stakeholders including R&D, Quality Assurance, Regulatory Affairs, Product Management, and Dev Ops.

Facilitate working sessions to understand how teams execute development activities and identify improvement opportunities.

Support alignment across distributed teams (North America, Europe, India, China).Process Improvement & Digitalization Identify inefficiencies and drive continuous improvement initiatives in software development processes.

Contribute to transformation toward:

Digital, artifact-driven evidence management

Agile and Dev Ops-aligned workflows AI-enabled process tools and insights

Required Qualifications Bachelor’s degree in Engineering, Computer Science, Quality, or related field3–10 years of experience in:

Medical device industry (preferred), or regulated software development

Software development lifecycle (SDLC), Agile, or Dev Ops environments

Understanding of:

Software requirements, architecture, and testing concepts

Design controls (e.g., requirements, V&V, traceability)
Medical device software standards (SaMD, Digital Health IT) and frameworks (e.g., IEC 62304 concepts)
Experience authoring or contributing to:

Procedures, work instructions, or technical documentation

Interest or experience in:

Digital transformation, process automation, or AI tools

Key Skills & Competencies Process orientation:
Ability to translate complex development practices into structured, scalable processes

Technical literacy:
Working knowledge of software development and system lifecycle concepts

Collaboration:

Strong ability to work across global, cross-functional teams

Facilitation:
Ability to lead discussions, workshops, and process alignment…