System Design Engineer

Proffice arbetar för en modernare arbetsmarknad. Vi förstärker företag och organisationer med nya medarbetare, temporärt genom uthyrning och permanent genom rekrytering. Proffice är en utpräglad serviceorganisation och för att trivas hos oss måste du brinna för att ge service och göra ett bra jobb. Proffice är ett av de äldsta och största bemanningsföretagen i Sverige med kontor över hela landet. The assignment is to act as a System Design Engineer regarding developing Bioprocess Systems and Columns. The assigment consist of As a System Design Engineer you are a part of CBS Functional Design team, which includes .Involvement with RFQ phase of the sales process including o Customer RFQ specifications review o Internal technical specification review .Functional Design including o URS review with customer o Design participation in POR (Project Order review) o Defining a Functional Specification for each product o Identify and approve ordering Long Lead Items o Internal design reviews o External Design reviews with customers and suppliers .Detailed Design o Support detailed designer with system level knowledge and investigations .Others o Investigations regarding Service questions o Investigations regarding quality issues o Investigations regarding Design related production issues o Investigations regarding R&D activities Overall - a System Design Engineer is the contact for taking care of Design issues from customer RFQ to IQ/OQ at customer site Qualifications: .Experienced system designer, at least 5 years experience, preferably within Medical equipment industry .Fluent in English, written and spoken .Good knowledge about GMP and preferably GAMP documentation Desired: .Experience from designing process equipment .Experience from pressure vessel directives such as PED, ASME and other authority regulations .Experince from handling CE approval activities The work is done in customer projects in close collaboration with Mechanical and Automation Designer at CBS. It is important that you are driven with a good sense of urgency, able to handle stressful situations, able to come up with new ideas and suggestions in short term but also being a team worker with high quality thinking.