Human Factors Specialist (m/f/d) Partnerships

at  Olympus Europa SE Co KG

Your responsibilities

• 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

Your qualification

• 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

Your benefits

• 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

• 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 requirement