Human Factors Engineer – Drug Delivery Devices (m / w / d)
Shape the Future of Patient-Centered Medical Device Innovation
For our client, a globally leading pharmaceutical company driving innovation in life sciences and patient care, we are seeking a dedicated Human Factors Engineer (m / w / d) to support critical regulatory submissions for parenteral drug delivery systems.
* Start Date : Immediately
* Location : Remote / Switzerland
* Employment Type : Permanent Position
About Our Client
For our client, a world-renowned pharmaceutical enterprise at the forefront of cutting-edge therapies and medical device development, we are looking for an experienced professional. This organization is recognized for its pioneering work in biotechnology and commitment to improving patient outcomes through innovative drug delivery solutions. With a strong emphasis on regulatory excellence and cross-functional collaboration, they offer an environment where scientific expertise meets real-world impact.
Your Responsibilities
* Revise and optimize summative study protocols and Instructions for Use (IFUs) based on regulatory feedback from health authorities
* Lead the planning, preparation, and supervision of summative Human Factors validation studies for parenteral delivery devices
* Manage external vendors throughout study execution phases, ensuring quality standards and timely delivery of comprehensive reports
* Author detailed HFE Summary Reports in compliance with FDA and international regulatory requirements
* Finalize all Human Factors Engineering documentation to support BLA (Biologics License Application) submissions
* Facilitate ongoing alignment with cross-functional teams including regulatory affairs, clinical development, and quality assurance
* Ensure adherence to FDA guidance on Human Factors and usability engineering standards (ISO 62366, AAMI HE75)
* Support risk management activities related to use-related hazards in combination products
Your Profile
* University degree in Human Factors Engineering, Biomedical Engineering, Psychology, or a related scientific discipline
* Proven experience in Human Factors studies for drug delivery devices, preferably parenteral systems (auto-injectors, prefilled syringes, or similar)
* Strong knowledge of FDA regulations and guidance documents for combination products and medical devices
* Expertise in designing and conducting formative and summative usability studies
* Excellent English language skills (written and spoken) for technical documentation and stakeholder communication
* Familiarity with pharmaceutical industry systems and processes is highly advantageous
* Strong vendor management and project coordination capabilities
* Ability to work independently in a remote setting with minimal supervision
* Excellent communication skills for cross-functional collaboration across international teams
Why Join Us?
At nemensis ag, we've connected thousands of candidates with their dream careers and provided opportunities for professional growth and market re-entry. What can we do for you and your career today? Get in touch with us!
This is your chance to make a meaningful impact in the pharmaceutical industry by ensuring that life-saving therapies are delivered safely and effectively to patients worldwide. As a Human Factors Engineer (m / w / d) working remotely from Switzerland, you'll contribute directly to regulatory success and patient safety.
Ready to take the next step? We look forward to hearing from you!
Contact
Branche : Pharma-Industrie
Funktion : Qualitätsprüfung
Anstellungsart : Freelance Arbeit
Karrierestufe : Angestellte / r
#J-18808-Ljbffr