Software Development Process Engineer / Specialist (Medical Device)

Key Responsibilities

• 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.
• 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).
• 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.