Lead Medical Device Design Engineer to AstraZeneca Gothenburg

Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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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.

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

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)

Varaktighet, arbetstid
Heltid Tillsvidareanställning

Publiceringsdatum
2018-05-16

Ersättning
Enligt överenskommelse

Så ansöker du
Sista dag att ansöka är 2018-05-31
Klicka på denna länk för att göra din ansökan

Kontakt
HR-avdelningen, Alten

Företag
Alten Sverige AB

Adress
Alten Sverige AB
Theres Svenssons gata 15
41755 Göteborg

Kontorsadress
Theres Svenssons gata 15, Göteborg

Jobbnummer
4145504

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