Software Development Process Engineer / Specialist (Medical Device)

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 DevOps.
• 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 DevOps-aligned workflows
• AI-enabled process tools and insights
• Required Qualifications
• Bachelor's degree in Engineering, Computer Science, Quality, or related field
• 3-10 years of experience in: Medical device industry (preferred), or regulated software development
• Software development lifecycle (SDLC), Agile, or DevOps 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 sessions
• Communication: Strong writing skills with attention to clarity, compliance, and structure
• Analytical thinking: Evaluate workflows and identify opportunities for improvement
• Proactive mindset: Driven to improve processes and enable organizational success
• Why Join Us?
• This role offers a unique opportunity to:
• Influence how medical device software is developed at scale
• Partner with global engineering, quality, and cross-functional teams
• Contribute to digital transformation initiatives including AI-enabled processes
• Build broad domain knowledge across product development
• Grow into multiple career paths (process leadership, quality, product development, or digital transformation)
• How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, profession

Benefits

Additional Information

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. 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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at onehealthineers? Share your experience