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System Analyst & Validation Engineer - Siemens Healthineers
Software Engineer
Lead the optimization of a multi‑site Test Data Management System, driving quality control, regulatory compliance, and digital transformation while bridging business analysis and validation engineering in a manufacturing and software development environment.
About the role
Key Responsibilities
- Design, implement, and maintain the Test Data Management System across multiple sites, ensuring data integrity and accessibility.
- Lead validation activities, including test planning, execution, and documentation to meet regulatory standards.
- Collaborate with cross‑functional teams to translate business requirements into technical specifications and system enhancements.
- Conduct quality control audits, identify process gaps, and recommend improvements to enhance product reliability.
- Drive digital transformation initiatives by integrating advanced analytics and automation into the TDMS workflow.
Requirements
- Proven experience in system analysis and validation engineering within a regulated manufacturing environment.
- Strong knowledge of regulatory frameworks (e.g., FDA, ISO 13485) and quality management systems.
- Hands‑on expertise with Test Data Management tools and software development practices.
- Excellent analytical, problem‑solving, and communication skills.
- Ability to work independently and collaboratively in a fast‑paced, global team.
Skills
software development