Human Factors Engineer to AstraZeneca
Dfind Science & Engineering AB / Logistikjobb / Göteborg
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Would you like to become a part of the design and developing of devices for inhalation drug administration at AstraZeneca - then this could be the right consultant assignment for you.
The Arena:
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
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
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-04-09. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Sara Kuikka
sara.kuikka@dfind.se 0725-487688
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-03-27ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-09
Ange följande referens när du ansöker: 201129975
Klicka på denna länk för att göra din ansökanKontaktSara Kuikka
sara.kuikka@dfind.se 0725-487688
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 4049388
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