Ihre Aufgaben
- Oversee and manage HFE activities conducted by external service providers, ensuring alignment with internal goals and regulatory standards
- Act as the primary point of contact between the internal team and external partners, fostering clear communication and collaboration
- Review and evaluate HFE deliverables from external partners such as use specifications, use related risk assessments, test plans, and reports
- Conduct and manage the execution of formative and summative evaluations to ensure products meet design specifications and are safe for use in medical settings
- Follow design control processes and ensure compliance with relevant regulations, such as FDA and ISO requirements
Ihre Qualifikationen
- Degree in Human Factors / Usability Engineering, Engineering, Biomedical Engineering, or within a related field
- 3-5+ years of experience in human factors engineering or usability engineering, preferably within the medical device or healthcare industry
- Experience in managing external designers, usability test agencies and recruiters
- Deep knowledge of related FDA and ISO regulations for medical devices and experience with design control processes
- Fluent language skills in German and English
- Excellent communication, problem-solving, and teamwork skills
- Strong attention to detail and commitment to quality
Ihre Vorteile
-30 days of annual leave
-Up to 60% mobile work possible + flexible work time model with overtime compensation
-Holiday and Christmas bonuses
-Corporate benefits discounts for employees
-Comprehensive company pension scheme and capital-forming benefits
-Company restaurant with live cooking and healthy food (subsidized)
-Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
-Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
-Various subsidized company sports groups and access to the inhouse company gym