The position involves working as a human factors engineer, responsible for ensuring that drug delivery devices are intuitive, safe and effective for every user. This role plays a critical part in the development of combination products and medical devices.
Responsibilities
1. Evaluate and improve device usability by conducting formative and summative studies, writing study protocols and reports, and analyzing results.
2. Develop use-related risk management documentation, such as task analysis, hazard assessments and use-related risk assessments, to ensure compliance with regulatory requirements.
3. Create design control documents, including user requirements and design input specifications, to guide the development process.
4. Author submission documents related to human factors engineering, including briefing books and summary reports.
5. Collaborate with external suppliers to manage services like usability studies, create instructions for use and training materials.
6. Represent human factors engineering within device teams, technology centers and technical development teams, applying knowledge of regulatory landscapes to ensure standard-compliant designs.
Requirements
* University-level education in an engineering discipline or related field and at least 4 years of experience in human factors engineering, preferably within medical device and drug-device combination product development.
* Demonstrable knowledge of drug delivery devices, spanning small molecules and large molecules, including oral, parenteral, pulmonary devices.
* Experience designing formative and summative usability studies, including protocol development, IRB submissions, data analysis and report writing.
* Sound knowledge of legislation, regulation, industry standards and guidance within combination products and medical devices, specifically usability engineering.
* Technical knowledge supporting electronic connected medical devices and software as medical devices; illustration skills with Adobe Illustrator and Photoshop; experience in developing instructions for use and training materials.
* Effective communication and presentation style; strong interpersonal skills; strong project management skills and efficient working style; fluent in English.
About Us
We're driven by a desire to innovate and make a global impact through healthcare solutions. Our team is dedicated to advancing science and ensuring everyone has access to healthcare today and in the future. We empower each other to explore new possibilities, foster creativity and keep our ambitions high.
We're committed to equality and diversity in the workplace.