Arbejde Medical Device Expert with design control responsibility Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse:
Medical Device Expert with design control responsibility

jobbeskrivelse:
- manufacturing - Denmark - Hillerød Would you like to have an impact on people's lives by ensuring the reliability of Novo Nordisk’s insulin pens and other medical devices? Do you have a passion for medical devices and an eagerness to bring your competencies and experience into play at one of Denmark’s most attractive workplaces? About the department The position is located in the design controls team, which holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from Research and Development (R&D) to production. The team consists 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. The position As design controls 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. 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. Your knowledge is also a valuable input to the design process when future devices are developed. 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 R&D. 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 ideally 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 English is a must. You are driven by the outlook of being the one person that safeguards the function and quality of the product you are responsible for. 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. You are able to work independently with day-to-day deadlines in critical situations as well as in maintenance projects with longer duration. Working at Novo Nordisk At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact For further information, please contact Linda Nilsson at +45 3075 0872. Deadline 4 July 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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