Biological Safety Engineer - Medical Devices (f/m/d)
Responsibilities:
* Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge
* Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists
* Support the development of biological strategy
* Assistance to representatives of the Business Division and HARTMANN in working groups related to changes in legislation or standards
* Establish and maintain contacts with testing institutes and external service providers
* Collaborate with departments like R&D, Manufacturing Engineering and Procurement to ensure biological evaluations comply with EN ISO 10993
* Assess biocompatibility of materials, support product registration, and contribute to risk analysis and clinical evaluation reviews
Qualifications:
* Degree in natural science, life science or engineering
* Knowledge in scientifc and/or clinical working (e.g. chemical, microbiological or quality lab)
* Knowledge in the field of medical devices, regulatory affairs or quality management desired
* Willingness to learn about new technologies and materials
* Analytical, organizational and communication skills
* Fluency in German and English
Benefits:
* Flexible working conditions, such as flexible working hours and mobile working
* Attractive ways of combining work and family life, e.g. childcare subsidy
* 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
* Company pension plan with attractive employer contribution incl. matching model for deferred compensation
* Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
* Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
* Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
* Job Bike Leasing
* Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform