Research & Development Engineer

GETINGE

Qualifications:

• 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

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