QUALIFICATIONS AND JOB DESCRIPTION
We are looking for a "R&D Engineer" for one of our global & multinational customer who operates in the medical sector.
JOB DESCRIPTION:
• 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 Test Method Validations
• Actively contributing to engineering change control system
REQUIREMENTS:
• Bachelor’s degree in Engineering; preferably Industrial / Mechanical/Material Engineering, Biomedical Engineering
• Preferably 3 years 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
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