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Medical Device Engineer with focus on Design Control

Vacante en Dinamarca (HOVEDSTADEN) de Ingenieros industriales y de producción

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros industriales y de producción.

Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for naturvidenskab og ingeniørvirksomhed : Ingeniørarbejde (undtagen inden for elektroteknologi) : Ingeniørarbejde i industri og produktion

Descripción de la oferta de trabajo:

Radiometer’s Medical Device for transcutaneous monitoring (TCM) is developed to care for patients in Neonatal Departments, Intensive Care, Sleep Labs and Home Care. This job allows you to care for the development of these devices through communicating and collaborating with R&D Engineers, QA and RA Specialists in Denmark and Switzerland in particular regarding Risk Management but also in  Design Control, and Product Requirements. Hiring manager, Stefan Teilmann, explains about the job and the department: “Having fun and developing on a personal and professional level is of high importance in our team and I am confident that we will reach and celebrate several important milestones with our new colleague in this newly established role. All our colleagues are welcoming this additional resource in the team so I predict a positive vibe in this job from the beginning.” 

Product Development and Quality Partner:

Your role will be Product risk manager for new TCM products and the successful candidate will combine system overview and technical curiosity with good interpersonal skills and flair for quality. We are confident that these competencies will ensure that the international collaboration in the project runs smoothly and we succeed.

Your tasks: 

• Be an active product development team member with focus on, and responsibility for, creating and maintaining the product risk analysis.

• Maintain a system view of the product portfolio and through the risk management process become an essential link between the quality department and development teams.

• Participate in cross-functional activities to develop unambiguous and feasible system requirements that support market needs as stated by product marketing

• Take part in creating system verification and validation protocols.

• Act as spokesperson for the need for design control, risk management and life cycle management in development of medical devices.

• Collaborate with system quality process and usability specialists in applying and maintaining our standard operating procedures, guidelines and document templates.

Contribute, grow and develop 

Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher. 

Application deadline is Wednesday the 2nd May 2018  

Start the application process by clicking "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.For further information, please contact Manager, TC Sensor Development Stefan Teilmann at tel. +45 22 46 93 32.

Qualifications

The preferred candidate holds a Master Degree in Engineering, Pharmacy, or similarThe following qualifications increases your chances of success in the job: • Experience with medical device development and ISO13485 

• 4+ years of experience in Design Control documentation (especially within Risk Management and Requirements Engineering) 

• Deep knowledge of regulatory requirements for medical devices and/or IVD in EU, US

• Ability to set local standards based on interpretation of regulatory legislation

• Proactive and ability to finalize tasks within deadlines

• Experience with cross functional and cross cultural project execution

• Experience with complex products containin

Servicio de empleo de origen: AMS, Servicios Públicos de Empleo, Dinamarca.

País del trabajo: Dinamarca.

Región: Hovedstaden.

Ver 694 ofertas de trabajo en "HOVEDSTADEN" (Dinamarca).

Fecha de inicio: 02/06/2018.

Nº de vacantes: 1.

Nivel educativo requerido: Sin especificar.

Cómo solicitar el puesto: Stefan Teilmann

Empresa: RADIOMETER MEDICAL ApS.

Contacto: Johannes Mols

Teléfono: 22469332.

Ver las 294 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros industriales y de producción ofertadas.

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