Human Factors Engineer at AstraZeneca
Söder & Co / Sjukhusteknikerjobb / Göteborg
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Söder & Co is an authorized recruitment and staffing company. We have long experience from the industry and know the importance of a strong local engagement. Since we are a full-service company in the staffing industry, we help our customers with competence and flexibility in all areas of the company. Our partnerships are based on long-term commitment, engagement, simplicity and trust.
It is going well for Söder & Co and a fun thing about that is that we need to hire more colleagues. At Söder & Co, we are always interested in connecting with the right people. For us, people are the ones who make a difference. We offer you market based wages, pension in accordance to collective agreement with Unionen, healthcare, fun employee activities and a high engagement from your closest boss. Our success is bases on your success. Welcome to us!
Om företaget
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.
The company:
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.
The position as Human Factors Engineer is as a consultant. As a consultant, you are employed by Söder & Co. The assignment will start in April and will last for one year with possible extension.
Dina arbetsuppgifter
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.
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
The position will be filled immediately. Interviews will be held continuously. If you find the role interesting, please apply through
www.soderco.se. If you have any questions regarding this position please contact Lina Friberg, Cherryl Jenkins or Niklas Ekeblad.
Din profil
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
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-03-06ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-03-18
Ange följande referens när du ansöker: 3119
Klicka på denna länk för att göra din ansökanKontaktLina Friberg
lina.friberg@soderco.seFöretagSöder & Co
AdressSöder & Co
Druveforsvägen 29
50433 Borås
KontorsadressDruveforsvägen 29
Jobbnummer 4004275
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