Medical Device Engineer
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is looking for a Medical Device 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 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
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 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 4004181
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