Job Description
About the Role:
* Develop complex medical devices, combining electronic, software, and mechanical expertise.
* Evaluate and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects.
* Maintain product conformity throughout the product life cycle, focusing on development, industrialization, and design control.
* Participate in risk analysis processes.
* Author and approve documents related to design verification, design validation, test plans, test setups, and experimental designs.
* Review and approve changes to product design and manufacturing processes.
* Serve as a liaison between customers and suppliers regarding product quality, including nonconformity reports, corrective actions, and supplier change notifications.
* Collaborate in equipment qualification, process validation, and evaluation of external production partners.
* Address quality-related inquiries during customer or authority audits.
Requirements:
* Tech or scientific education or equivalent.
* Multiple years of experience in medical technology products, pharmaceuticals, or in-vitro diagnostics.
* Prior experience in risk management methods for medical devices.
* Familiarity with quality and problem-solving techniques.
* Knowledge of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485).
* Ability to work methodically and prioritize tasks effectively.
* Willingness to take proactive steps and make decisions.
* Solution-oriented and communicative personality.
* Confidence in communication across all levels, internally and with customers.
* Ability to travel up to 10%.
* Excellent German (B2) and English (C1) language skills.