Your mission
* Define information structures: Continuously optimize information structures, documentation processes, and templates in the PLM ecosystem to ensure regulatory compliance and operational efficiency throughout the product lifecycle
* Ensure the completeness of the DHF/DMR: Maintain a complete, accurate, and compliant Design History File (DHF) and Device Master Record (DMR). Take ownership of the Project Data Plan and Phase Gate checklists in accordance with global regulatory standards and internal quality objectives
* Create a structured filing system: Develop and maintain a lean, transparent, and comparable project structure for all projects and immediately report any missing, time-critical elements of the DHF/DMR to the project manager
* Develop strategies for legacy products: Provide guidelines for updating technical documentation for existing products to ensure efficient compliance
* Prepare and conduct audits: Ensure that all project-related documents and evidence (e.g., DHF, DMR, development documentation, test reports) are complete, up-to-date, and audit-compliant. Act as the main contact person for auditors, coordinate audit preparation, and represent development projects during audits
* Ensure design traceability: Ensure that anomalies in predecessor and similar products are processed in new product versions and that safety and quality aspects are included in a comprehensible requirements management system
* Knowledge and implementation of standard requirements: You have in-depth knowledge of IEC 60601-1 and relevant electronic components to ensure the electrical safety, performance, and compliance of medical devices
Your talents
* Completed degree in natural sciences or engineering
* Proven knowledge of Design History File (DHF), Device Master Record (DMR), and global regulatory standards (e.g., ISO 13485, FDA)
* Ability to define, optimize, and maintain information structures and documentation processes in the PLM environment
* Ability to efficiently organize complex documentation, prepare audits, and ensure a transparent project structure
* Confident manner as a contact person for auditors and project teams, including coordination of audit preparations and interdisciplinary collaboration
* Very good English skills
Your Benefits
* Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required
* 30 vacation days and various special payments
* Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more
* Corporate benefits and bicycle leasing
* Subsidy for private pension plan and company health management
* Various childcare options – at the headquarters in Tuttlingen
* Health, sports, cultural and leisure activities – offers vary depending on location