At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.
Join our team as
Specialist Biological Evaluation (f/m/d) - 24 months
DEU-Heidenheim
Are you passionate about biological evaluations and ensuring the safety of medical devices? In this role you support our efforts in the field of biological evaluations for products such as drapes, dressings, instruments, and gloves. In this role, you will interpret ISO 10993 requirements, develop biological evaluation strategies, and collaborate with external labs and toxicologists to ensure compliance with industry standards. You will also represent our business division Risk Prevention in working groups, maintain key relationships with testing institutes, and support cross-functional teams to ensure the highest safety standards for our products.
This position is a parental leave replacement and temporary for 24 months.
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
Shape a career that’s focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.
Your personal contact:
Sophia Zoller
At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.
Join our team as
Specialist Biological Evaluation (f/m/d) - 24 months
DEU-Heidenheim
Are you passionate about biological evaluations and ensuring the safety of medical devices? In this role you support our efforts in the field of biological evaluations for products such as drapes, dressings, instruments, and gloves. In this role, you will interpret ISO 10993 requirements, develop biological evaluation strategies, and collaborate with external labs and toxicologists to ensure compliance with industry standards. You will also represent our business division Risk Prevention in working groups, maintain key relationships with testing institutes, and support cross-functional teams to ensure the highest safety standards for our products.
This position is a parental leave replacement and temporary for 24 months.
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
Shape a career that’s focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.
Your personal contact:
Sophia Zoller