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Senior Human Factors Engineer Medical Device

Inseriert am: 04.03.2019

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Apply to JobJob ID262859BRPosition TitleSenior Human Factors Engineer Medical DeviceJob DescriptionThe successful candidate will join the Human Factors team in the Device Development Department in TRD Novartis to lead human factors activities and user interface development of medical devices, combination products and associated software/apps.

The position offers opportunities to work in multidisciplinary and international teams, across multiple projects, where human factors and is a key element for success.

The candidate will also act as a key advocate for Human Factors principles across the company.

The Human Factors Engineer will provide expert input to the device development teams to establish system, design, operating requirements for the device, the packaging, the labeling, user interface and the training. To understand and inform the design the candidate will be responsible for independently leading, planning, executing and reporting of human factors studies with users to evaluate the user interface design. These activities will be conducted according to current regulations and guidelines (EMA, FDA, Local regulations) within the medical device and pharmaceutical industries.

Management competences are required to set up the Human Factors strategy, plan the activities according to the project planning, and manage the external partners supporting the development and evaluation. Communication and negotiation skills are key to influence a large number of stakeholders as Human Factors interacts with multiple functions.

Typical activities are:

• Provides human factors support throughout the product development lifecycle including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts, generation of instruction for use (creation graphical user interfaces, and product graphics), user interface design and instructions for use.

• Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team either using external vendors or using internal facilities.

• Defines appropriate sample sizes and statistical methods for analysis.

• Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.

• Cross-examines and provides ergonomic, usability and safety assessments for healthcare products, medical devices, instruction for use and secondary packaging. Propose design optimization of the developed product.

• Leads instruction for use (IFU) design and development including validation.

• Develops and implements human factors research methodologies.

• Support definition of internal procedures and templates for the execution of human factors engineering activities.

• Works independently against self-set targets.

Minimum requirementsBachelor’s or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline. Excellent skills in English, verbal and written are required. Other language skills, e.g. French, German are advantageous.

An ideal candidate would have a relevant degree and 5 to 10 years of experience in applying Human Factors Engineering/usability to medical devices development, preferably in the pharmaceutical industry, including:

• Good understanding and specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission

• Experience in project / program management

• Experience in developing and documenting Human Factors activities for medical devices as required by regulation

• Experience in managing user studies (performed by vendors or self-managed)

• Good understanding of the risk management activities

• Experience in developing apps, software and/or industrial design would be advantageousDivisionGlobal Drug DevelopmentBusiness UnitTECHNICAL R & D GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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