Human Factors Engineer
Poolia Göteborg AB / Datajobb / Göteborg
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hela Sverige Are you looking for a new job career challenge within management and medical device development? Do you have hands-on passion for your work togheter with an interest of communicate your work verbally and orally? Then you might be the consultant AstraZeneca are looking for! As a Senior Human Factors Engineer you will lead the execution of the human factors engineering process for medical device and combination products across projects. This is a 1 year consultant assignment with start date as soon as possible. Next step, apply today!
about the consultant assignment
AstraZeneca has a long-standing reputation as being a leader in advanced Drug Delivery products. At the beginning of 2016, Pharmaceutical Technology and Development (PT&D) became an integral part of Global Operations. A global organization with 1,100+ workforce disbursed across UK, Sweden, Germany, US and China, with additional colleagues located at key manufacturing sites. We support launched and development portfolios.
With innovation at the center of everything we do, we design and deliver the active drug product (including formulations, devices and packaging) required to support new medicines - from products to be used in toxicology studies and clinical trials to development of the technology to ensure that drug products can be scaled up for manufacturing on a commercial scale. Inhalation Product Development (IPD) Device & Packaging Gothenburg is a team within Pharmaceutical Technology and Development (PT&D) and our team focuses on designing and developing devices for inhalation drug administration and packaging of pharmaceuticals and devices.
The role:
We are looking for a Senior Human Factors Engineer to lead the execution of the human factors engineering process for medical device and combination products across projects. The Senior Human Factors Engineer is responsible for establishing the Human Factor File for development projects and manages external human factors partners to meet project goals. You will also represent human factors engineering in cross functional design core teams. Candidates must show a hands-on passion for their work and be able to communicate their work both verbally and visually. Candidates must have an ability to integrate feedback and to respond quickly to changing contexts and work environments.
Activities typically includes, but limited to:
• Plan human factors activities for projects and provide input to overall project planning
• Ensure timely execution of HF studies for assigned projects
• Generate and ensure approval of all AZ device human factors engineering documentation
• Provide input and support for risk management activities
• Provide device usability input/support to design inputs and design specifications
• Be the AZ HFE laison with HF vendors to deliver defined HFE work packages
• Project manage the supply of materials for use in HF studies and associated documentation
• Lead the development of AZ device Instructions for Use (IFU)
• Support the development of device labelling and packaging
• Support the generation of device regulatory submission
• Support human factors research to augment present and future device projects, including in-house laboratory testing and external research with the support of contract staff/vendors
Who you are
Minimum requirements:
• BS degree preferred in Human Factors/Usability Engineering, Cognitive Psychology or other relevant degree
• MS Degree preferred
• 5+ years' experience of relevant Human Factors/Usability engineering experience in medical devices or other relevant regulated industry
• Extensive knowledge of IEC 62366 Medical Devices - Application of Usability, FDA Human Factors guidances and MHRA guidances
• Understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
• Experience in establishing DHF documentation
• Excellent organizational and communication skills (oral and written).
• Ability to work on teams as well as individually
• Good leadership and interpersonal skills
• Good technical and regulatory writing skills
• Fluent in English
About Poolia & AstraZeneca
Poolia take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Next step, apply today!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-03-19ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-03-26
Ange följande referens när du ansöker: 49648
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4030920
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