System Analyst & Validation Engineer

Siemens Healthineers

About The Position

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. This position plays a pivotal role in managing and optimizing a multi-site Test Data Management System (TDMS) within a dynamic manufacturing and software development environment. The selected candidate will drive quality control, regulatory compliance, and digital transformation by acting as both Business Analyst and Tester, collaborating with cross-functional teams to enhance workflows and implement scalable solutions. Reporting directly to the manager of the TDMS application, this individual will ensure the integrity and efficiency of data management processes supporting manufacturing and labeling operations. As a key contributor in a dynamic manufacturing and software development landscape, you will: Serve as the subject matter expert for a multi-site Test Data Management System (TDMS) (Specialized in house application) that serves as Lab Information Management Systems (LIMS) and Labeling Systems (Product Labels and Inserts supplied by the Manufacturer) that generates digital and paper-based materials. Configure, optimize, enhance and maintain the TDMS application to support quality control testing, printing, and the digital delivery of product materials, ensuring alignment with evolving manufacturing needs. Safeguard the integrity, traceability, and regulatory compliance of manufacturing data across all digital systems and workflows. Fulfill dual responsibilities as Business Analyst and Tester for TDMS, applying best practices in requirements gathering, analysis, and solution verification & validation. Collaborate cross-functionally with Manufacturing, Quality, Labeling, and IT teams to collect, analyze, and document both business and technical requirements, driving efficient digital transformation initiatives. Identify process inefficiencies and workflow /technology gaps, and champion the implementation of scalable, data-driven solutions to enhance operational performance. Translate manufacturing and quality objectives into actionable user stories, functional specifications, and comprehensive test cases for continuous system improvement. Design, execute, and document system, integration, and regression testing in a hybrid (Waterfall and Agile) development environment, ensuring robust software quality. Prepare and maintain essential Quality Engineering/Assurance documentation, supporting streamlined compliance in highly regulated industries. Develop and update work instructions, procedures, and user documentation to be compliant and to facilitate effective system adoption and knowledge transfer. Lead incident analysis (e.g., CAPA, QN), manage defect triage, and drive root cause investigations related to manufacturing test data and system behavior, fostering a culture of continuous improvement. Contribute to system enhancements, verification, validation (CSV) activities, and ongoing optimization initiatives leveraging modern software development methodologies.

Requirements

Bachelor’s degree in Biology, Chemistry, Information Systems, Engineering, Computer Science, or equivalent professional experience.
Demonstrated expertise with LIMS systems (like TDMS) as a Subject Matter Expert, Business Analyst, System Analyst, Developer or Test Engineer.
Established background in Manufacturing Quality Control for assays, with a proven ability to manage and optimize test data and related processes.
Practical, hands-on experience managing manufacturing test data, supporting manufacturing systems, or maintaining quality control systems in a regulated setting.
Experience operating in highly regulated environments—preferably in manufacturing, healthcare, or life sciences—ensuring compliance and best practices.
Proficient in validation documentation (IQ/OQ/PQ) and familiar with Computer System Validation (CSV) standards within regulated industries.
Strong knowledge of the software development life cycle (SDLC), requirements management, and software testing methodologies within hybrid Waterfall and Agile environments.
Exceptional communication skills, enabling effective collaboration with both technical and non-technical stakeholders across cross-functional teams.
Advanced analytical, documentation, and problem-solving capabilities to support process improvements and sustain system excellence.

Nice To Haves

Hands-on experience with Application Life Cycle Management (ALM) tools, such as Microsoft ADS, to System development in regulated environments.
Test Management in Microsoft ADS is a plus.
Familiarity with leveraging AI tools to enhance process efficiency, data analysis, and operational excellence.
Proven ability to work effectively within Agile or hybrid project methodologies, ensuring flexibility and compliance with industry standards.

Responsibilities

Serve as the subject matter expert for a multi-site Test Data Management System (TDMS) (Specialized in house application) that serves as Lab Information Management Systems (LIMS) and Labeling Systems (Product Labels and Inserts supplied by the Manufacturer) that generates digital and paper-based materials.
Configure, optimize, enhance and maintain the TDMS application to support quality control testing, printing, and the digital delivery of product materials, ensuring alignment with evolving manufacturing needs.
Safeguard the integrity, traceability, and regulatory compliance of manufacturing data across all digital systems and workflows.
Fulfill dual responsibilities as Business Analyst and Tester for TDMS, applying best practices in requirements gathering, analysis, and solution verification & validation.
Collaborate cross-functionally with Manufacturing, Quality, Labeling, and IT teams to collect, analyze, and document both business and technical requirements, driving efficient digital transformation initiatives.
Identify process inefficiencies and workflow /technology gaps, and champion the implementation of scalable, data-driven solutions to enhance operational performance.
Translate manufacturing and quality objectives into actionable user stories, functional specifications, and comprehensive test cases for continuous system improvement.
Design, execute, and document system, integration, and regression testing in a hybrid (Waterfall and Agile) development environment, ensuring robust software quality.
Prepare and maintain essential Quality Engineering/Assurance documentation, supporting streamlined compliance in highly regulated industries.
Develop and update work instructions, procedures, and user documentation to be compliant and to facilitate effective system adoption and knowledge transfer.
Lead incident analysis (e.g., CAPA, QN), manage defect triage, and drive root cause investigations related to manufacturing test data and system behavior, fostering a culture of continuous improvement.
Contribute to system enhancements, verification, validation (CSV) activities, and ongoing optimization initiatives leveraging modern software development methodologies.