Senior Human Factors Engineer page is loaded
Senior Human Factors Engineer
Apply locations Basel time type Full time posted on Posted 9 Days Ago job requisition id 202507-116953
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
The Global Device & Packaging Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.
Our Human Factors group plays a critical role in bringing these innovations to patients worldwide. We are at the forefront of developing combination products and medical devices that are intuitive, safe, and effective for every user.
The Opportunity
Your specific responsibilities and key activities of this position include:
* Establish the Human Factors Engineering strategy for development programs and ensure it is reflected in the development planning
* Plan, design and manage Human Factors studies including formative and summative evaluation. Write and review study protocol and reports. Analyze study results, ensure they are transferred into the risk management process and provide development teams with conclusions
* Establish and maintain use-related risk management documentation, such as task analysis, hazard assessment and use-related risk assessments
* Author and review Human Factors related design control documentation including user requirements and design input specifications
* Author and review submission documentation related to Human Factors, including briefing books and Human Factors Engineering summary reports
* Manage collaboration with external suppliers. Define the scope of and manage the execution of external services, such as usability studies. Create instructions for use and training material
* Represent Human Factors Engineering in Device Teams, Technology Centers and Technical Development Teams. Apply your sound knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems, risk management and design control
Who you are
* You bring a university level education (engineering degree or related discipline) and at least 4 years of work experience in Human Factors engineering within medical device and preferably drug-device combination product development.
* Demonstrable knowledge of drug delivery devices, spanning both small molecules and large molecules - including oral, parenteral, pulmonary (e.g. devices such as oral dispensers, injection pens, auto-injectors, reconstitution devices, patch/pumps, pre-filled syringes, inhalers, ocular delivery or other novel injection technologies)
* Experience in 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 the area of combination products and medical devices, specifically as it relates to Usability Engineering. Experience with direct health authority interaction is a plus.
* Preferably technical knowledge to support the development of electronic connected medical devices and software as medical devices. Illustration skills with Adobe Illustrator and Adobe Photoshop, and experience in developing instructions for use and training materials
* Effective communication and presentation style; Strong interpersonal skills, experienced in working in multi-functional and cross-cultural environment; Strong project management skills and efficient and well organized working style; Fluent in English, with strong technical writing skills. Preferably proficient in German
Are you a Human Factors Engineer keen to join an exciting team that loves to make an impact? We would love to hear from you. Please apply by submitting your CV and cover letter.
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.
About Us
We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
#J-18808-Ljbffr