Senior Medical Device Design Engineer Lead
Poolia Göteborg AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige Are you looking for a new job career challenge at AstraZeneca Gothenburg? Do you want to lead mechanical design of a drug delivery device? Then you might be the senior medtech consultant we are looking for! The consulting assignment will start in June and go on for 12 months. Please feel free to contact me if you have any questions before your application. Looking forward to hearing from you. Warmly welcome to Poolia and AstraZeneca.
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 Team Leader for Senior Medical Device Design Engineers to lead the mechanical design of a drug delivery device. You will lead a team of design engineers and external partners through the entire product development process, from concept generation to final commercial design. You will represent mechanical design in a cross functional design core team. You will play a role in defining processes and methods to ensure timely and qualitative output from the design team. You will identify and initiate investigations of medical device technologies, prototype and test solutions for device features. You will demonstrate a working knowledge of mechanical systems. Experience in systems integration of electronics products is a plus. 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 Medical Device Design Engineer teams
• Develop dynamic mechanical systems
• Design and test systems and subsystems to meet project objectives
• Select materials and component technologies to meet project objectives
• Apply technical expertise to problem solving throughout product life-cycle
• Participate in a cross functional design process, combining your skills with other disciplines, such as Risk Management and Human Factors, to develop effective designs
• Produce prototypes and perform engineering evaluations
• Collaboration with external design partners as well as external manufacturing partners
• Generate detailed design and product regulatory documentation for the DHF
• Encourage new ideas and solutions to overcome design challenges
Who you are
Minimum requirements:
• 5+ years' experience working in development of medical devices or other relevant regulated industry as a Design Engineer and Team Leader or other Leading positions.
• Good 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
• Good understanding for medical device technical standards; ISO, IEC, FDA guidances
• Good technical and regulatory writing skills
• Excellent leadership, organizational and interpersonal skills.
• Ability to work on teams as well as individually
• Good communication skills in English (oral and written)
About AstraZeneca
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. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
What's in it for you?
• Collective agreement with Unionen (
https://www.unionen.se/rad-och-stod/om-kollektivavtal) • Strong benefits/offers designed for your need
• Individual career support
• Encouraging life career
• Broad professional network
• Committed consultant manager
Please feel free to contact me if you have any questions before your application.
Looking forward to hearing from you. Warmly welcome to Poolia!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-05-15ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-05-22
Ange följande referens när du ansöker: 49653
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4144255
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