QUALIFICATIONS AND JOB DESCRIPTION
Ever since Maquet's founding in Germany in 1838, it has helped hospitals with innovative products such as the first motorized operating table. A Maquet table was used for the first heart transplant surgery in 1967, in South Africa. Firsthand understanding of clinical challenges and continuous optimization of its products established Maquet as a leading provider of medical systems.
Today Maquet is a product brand within Getinge. The Maquet brand provides a broad range of products and innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, including operating rooms, hybrid operating rooms, catheter laboratories and intensive care units as well as intra- and inter-hospital patient transportation.
The production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US. In total, Getinge has over 12.000 employees in more than 41 countries. Getinge's head office is located in Gothenburg, Sweden.
• Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering, Biomedical Engineering
• Preferably 3 years experience in an industrial environment and medical device development (multinational company experience / medical industry is an asset)
• Excellent command of both written & spoken English; German is an asset
• Background and experience in project and production engineering
• Good knowledge of MS Office applications and an applicable knowledge of CAD (AutoCAD,Solidworks)
• Knowledge of statistical techniques
• Knowledge/experience of/with ISO 13485
• Knowledge /experienced of/in mechanical material testing (ISO/ASTM) and test method development
• Experience with medical device design control principals, Requirement Engineering and Risk management in Medical devices
• Good knowledge of problem solving tools (knowledge of 6 Sigma tools is a plus)
• No military obligation for male canditates
• Having ambition to develop his/her carreer in the medical industry
• Strongly creative with an analytical mind, able to use initiatives
• Able to work with multinational teams
• Good team working skills with the willingness to accomplish tasks in harmony with the other team members
• Interested and eager to learn & update his/her knowledge
• Disciplined way of working with a high ability to concentrate on both processes & results
• A critical mind with the desire & ability to put designed solutions into practice
• Demonstrative experience in documenting work procedures
• Not restricted to work during night shifts
• Experience in Quality System Environment is an asset
• Management and handling of product documentation
• Proactive in finding permanent solutions for engineering&design problems
• Leads and / or supports the design, development and implementation of disposable devices and components
• Conduct design verification & validation activities ( shelf life, product performance testing etc.)
• Creates, reviews and maintains technical documentation (DHF/DMR) according to established product development procedures and relevant regulations (MDR / 21CFR820)
• Closely collaborates with internal departments (Quality, Regulatory, Product Management, and Production) and external parties such as test laboratories, service providers and suppliers.
• Evaluates and implements requirements from applicable standards
• Design & management of new transfer projects including workflows, equipment, material, etc.
• Taking an active role in the selection & purchasing of equipments & machinery
• Drive the integration of new technologies in terms of equipment designs/upgrades
• Developing & implementing plans to improve quality, efficiency & the reducing of costs
• Preparing the main database (BOP, BOM, equipment data, etc.) as well as monitoring revisions, applying the analyses to the Document Management System
• Management of internal improvement activities & CAPAs
• Management and performing Process & Product Validations and Test Method Validations
• Actively contributing to engineering change control system