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Sr Human Factors Engineer

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Engineering, Design, Engineer, Usability

Projektbeschreibung

Preferred Qualifications

* Bachelor's degree in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline and 6 years of business experience, working in development organizations in multiple parallel and virtual development environments.
* MS in Human Factors, Industrial Design, Cognitive Psychology, or other Engineering/Life Sciences related discipline
* Minimum of 4+ years experience working in the development of electro-mechanical systems design, verification and validation
* Demonstrated time management, decision making, presentation and organization skills
* HF/ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal)
* Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
The position requires also requires the following:
* Proven experience in the HF/ID principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis
* Proven experience with using sketch models, low and high fidelity prototypes to identify and eliminate potential use errors early in the development process
* Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market
* Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction
* Knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging
* Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485:2003, 14971, EN 60601, Council Directive 93/42/EEC, etc.
* Experience in design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of medical device development
* Experience in writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports)

The Senior Human Factors Engineer will work with the Director of Human Factors to collaborate with internal and external team activities that assure brand driven aesthetics are applied consistently across the entire product portfolio. They will help with planning, execution and reporting of human factors engineering, user interface and industrial design studies across assigned device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries, ensuring that expert HF/ID input is provided to device design teams for enforcing design requirements, packaging requirements, training requirements and use instructions, design validation activities and clinical studies in support of regulatory submissions.

Ensures
* Human-system capabilities and limitations are properly reflected in the system requirements
* Human-system performance and safety risks are appropriately addressed in program baseline
* Assists in determining the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Los Angeles, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland