Medical Device Engineer
Poolia Göteborg AB / Kemiingenjörsjobb / Göteborg
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hela Sverige Are you looking for a new job career challenge in medical device development at AstraZeneca? Then you might be the consultant we are looking for. The consulting assignment will start as soon as possible and go on for 12 months. 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 Medical Device Engineer with experience of development of medical devices or other highly regulated mechanical systems to contribute to the development of drug delivery devices. You will lead or participate in development activities within the design team and interact cross functionally within the project team. You will contribute to the development of a high-quality Design History File.
You will demonstrate a working knowledge of mechanical systems. You will have the desire to learn from new challenges and the problem solving and communication skills to work within a diverse team. Candidates must show a hands-on passion for their work and be able to communicate their ideas and concepts 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:
• Lead or contribute to development activities within the Design team
• Contribute to the translation of User needs into technical Design Input Requirements
• Interact with test engineers to define mechanical tests for evaluations of designs
• Participate in selection and evaluation of materials
• Contribute to the development of design specifications and other outputs
• Support development of prototypes and perform engineering evaluations
• Collaborate with external design partners as well as external manufacturing partners
• Generate design documentation for the DHF
Who you are
Minimum requirements:
• 2-3+ years' experience working in development of medical devices or other relevant regulated industry as a Design Engineer
• Understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
• Pro/Engineer Creo experience preferred, other CAD is acceptable (Solidworks, CATIA)
• Experience in creating DHF documentation
• Understanding for medical device technical standards; ISO, IEC, FDA guidance
• Good technical writing skills
• Excellent organizational and interpersonal skills.
• Ability to work on teams as well as individually
• Good communication skills in English (oral and written)
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: 49651
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4030902
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