Job description

Your Tasks:

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.

Presentation and communication to project management and other internal stakeholders as well as to national and international partners.

Your profil:

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

System Engineer Consumables