Biological Safety Engineer

vor 1 Monat

Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit
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

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