- Development and maintaining of a portfolio of consumables for use with femtosecond lasers in ophthalmology, including requirement specification and design verification / validation
- Manage design transfer to manufacturers and have control over IQ / OQ / PQ
- Maintain close communication and collaboration with internal departments (procurement, service, production, validation, quality and regulatory) as well as external development partners and suppliers
- Push project tasks independently by collecting required information for design input and output.
- Manage design process and required technical documentation activities according to internal standards.
- Technical support for current and future business to ensure the ability to deliver products and services to customers.
- Lead investigations and root cause analyses. Focus on constant improvement of product quality and costs.
- Proactive input of ideas and projects into development pipeline.
- Presentation and communication to project management and other internal stakeholders as well as to national and international partners.
- Technical or Scientific University Degree
- At least 3 years of professional experience in the development of medical products, especially sterile disposable products.
- Solid experience and state-of-the-art knowledge of the Design Control Process for Medical Devices according to MDR and MDSAP requirements
- Experience in product and process validation of sterile disposable products for worldwide registration
- Expertise in the following standards is advantageous:
- ISO 14971: Medical devices - Application of risk management to medical devices
- IEC 62366: Application of usability engineering to medical devices
- ISO 11137: Sterilization of health care products
- ISO 11607: Packaging for terminally sterilized medical devices
- Very good German and English skills, both written and spoken
- Practice-oriented and autonomous working method