Human Factors Engineer (temporary for 1,5 years)

Job description

·  Job facts

Human Factors Engineer

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.

“Europe Biologics“ (PTDE) supports biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.

In a global, cross-functional environment the Basel Device Development organization develops drug delivery solutions for many different disease areas. Our medical devices are an integral part of these solutions. Within the organization the Human Factors section ensures that our medical devices are adequate from a usability perspective.

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

Your Profile
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.

You have the following skills and experience:

·  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
·  Preferably experience with direct health authority interaction
·  Preferably technical knowledge to support the development of electronic connected medical devices and software as medical devices
·  Preferably 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

·  Who we are

Bei Roche leisten 98,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.