Human Factors Engineer
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige In Gothenburg, ALTEN Pharma is looking for a Human Factors Engineer for a consultancy assignment at AstraZeneca.
ABOUT ASTRAZENECA:
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
ABOUT ALTEN:
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Nils Löfgren, Business Manager Pharma, at
nils.lofgren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-03-06ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-03-15
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4004192
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