Medical Device Specialist with Flair for Risk Management
Vacantes 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:
-?Research & Development -?Denmark - Hillerød Would you like to have a direct impact on people’s lives by ensuring the reliability of Novo Nordisk’s insulin pens and other medical devices? Do you think the complexity around navigating in a controlled environment with strict regulatory requirements whilst ensuring world-class productivity and product quality is an interesting challenge? About the department The position is located in the Design controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from R&D to production. The Design controls team consist of 12 skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and polymers. Each team member is responsible for one or more marketed products e.g. our high quality insulin pens. The position As Product responsible you will be a key person in the life cycle of your product. It is your responsibility to ensure that the product fulfils the defined requirements and that safety risks are identified and mitigated. You own the product documentation and are responsible for maintaining a high quality technical file which must be ready for audits and inspections at all times. On an everyday basis, you use your technical knowledge and tools like the safety risk analysis to provide expert input during production challenges, customer complaint handling, improvement projects etc. Your input has direct impact on our ability to deliver to the market, on patient safety and on compliance with the requirements of the authorities. Together with your colleagues you set direction on how Novo Nordisk performs design controls activities in the post-market phase. The position provides a unique opportunity to be involved in all aspects of a medical device in an international pharmaceutical company. To succeed you collaborate with a broad range of stakeholders in the organisation as Manufacturing Development, Regulatory Affairs, Quality Assurance, Global Safety and Research & Development. Qualifications As a minimum, you have a BSc in Mechanical Engineering or similar. Your possess 5+ years of experience within the development or manufacturing of medical devices or other products where quality and regulatory compliance are vital to succeed. You have a strong technical understanding and you have experience with one or more aspects of design controls e.g. requirements engineering, design verification and safety risk management. You will work in an international environment, hence solid skills in written and spoken English is a must. You are driven by the outlook of being the one person that our stakeholders turn to for product related decisions. You work completely independent both in critical situations as well as in maintenance projects with longer duration. You have proven experience in setting direction in cross-functional work settings. Strong personal dedication, integrity and networking skills are needed to set direction and make decisions in a complex stakeholder environment, often with diverging interests. You are well-structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Linda Nilsson at +45 3075 0872. Deadline 26 June 2017. Please note that we will invite candidates for interviews continuously throughout the posting period.
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.