Senior Research & Development Engineer

GETINGE

Together we can make a difference

At Getinge, we have a firm belief that every person and community should have access to the best possible care.  That is why we are dedicated and passionate about helping our customers save lives and ensure excellent care.  We provide products and solutions for hospitals and life science institutions within the areas of intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science.  A career at Getinge will provide career opportunities that both inspire and challenge.  Here, you can make a difference every day.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.

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