Senior Medical Device Design Engineer
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is searching for a Senior Medical Device Design 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 Medical Device Design Engineer 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:
• 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
MINIMUM REQUIREMENTS:
• 5+ years' experience working in development of medical devices or other relevant regulated industry as a Design Engineer
• 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 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 Rickard Westergren, Business Manager Pharma, at
rickard.westergren@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 4004185
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