Only fitting candidates will be contacted!
* 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. Assessment and evaluation of the urgency of problems. Highlighting top priorities to management.
* 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 of project progress and issues 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