stillingsbetegnelse: Requirements Engineering Specialist-MED000530

jobbeskrivelse:
About Us We save lives for a living The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2700 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 80 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than $ 684 million worldwide and is owned by US-based Danaher Corporation. Description Do you have experience with Design Control in the Medical Device business? As part of the New Product Development team in Copenhagen, you will work with highly skilled colleagues with reference to the Head of New Product Development in R&D. The New Product Development department is responsible for developing new blood gas analyzers from concept to market introduction, including Design Control documentation that fulfils regulatory and internal demands. Your responsibility will primarily be to lead the Design Control documentation within one or more projects in the New Product Development department. The job To become successful, you must have profound experience with Requirements Engineering and Design Control applied to development of Safety Critical Systams, ideally Medical Devices. Your responsibilities and tasks will include: •Leading the eRequirements Engineering and Design Control tasks within one or more projects in the New Product Development department to secure effective 510K approval and other registrations. •Leading the Safety Risk Management process, documentation, and reviews. •Building up Design Competencies within New Product Development. •Participating in project teams including meetings and reporting to management Travel activity of 5 to 10 days per year is to be expected. Qualifications "Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success: •A Master Degree in Engineering, Pharmacy, or similar. •Experience with medical device development. •Profound experience in Design Control documentation (especially within Risk Management and Requirements Engineering). •Knowledge of the medical device legislation (IVD, MDD) in EU and the US. •Knowledge of regulation and standards relevant for medical device development. •Fluent English is required, both written and spoken; fluent Danish is an asset. •Experienced MS Office user and familiar with working in databases. You must be passionate and committed about what you do, as well as: •Proactive and adding energy to the team by taking responsibility. You work well independently as well as in teams. •Focus on targets and results. Ability to handle and prioritize many projects at the same time, keeping deadlines. •Used to having a cross-functional and cross-cultural interaction. •Excellent analytical skills. We offer you A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits. For further information, please contact Head of New Product Development Søren Karsberg at tel. 2073 0432. Interviews will be held a

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

Arbejdsgiver telefonnummer: 38272829

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark