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reference: 4952506

documentId: 4952506

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lastModificationDate: 1551429736043

stillingsbetegnelse: Product Risk Manager for Immunoassay R&D

jobbeskrivelse:

Description

Cardiovascular diseases like myocardial infarction (heart attack) and acute coronary syndrome are some of the most prevalent causes of death in the western world with an estimated 18 million deaths each year on a worldwide basis. In Radiometer, you can join a dedicated and specialized R&D team in the journey to improve early diagnostics helping caregivers make decisions that can save lives.

 

Our Immunoassay Diagnostic Platform

The Immunoassay team recently celebrated 10-year anniversary of our AQT immunoassay diagnostic platform. We need you and your product risk management skills to help us identifying hazardous situations and ensure that our products are safe. You will be inviting your technically skilled and problem solving oriented colleagues to discuss observations from the market, potential errors in our products, how often they may occur, and how we can prevent them from occurring. You can look forward to a job, where every day is different: 

• One day you may spend time in the laboratory with laboratory technicians going through a protocol that can rule out potential performance issues with our immunoassays
• The next day you may be looking into statistical databases and post-market surveillance data and discuss evidence with our colleagues in Medical Affairs
• Another day you may be discussing future immunoassay product upgrades and requirements specifications to control risks with input from subject matter experts from many different areas.  

 

Keeping our CE marking in the future as well as complying with the new IVDR regulative is also an important aspect of your job. By managing product risk analysis and keeping track of post-market surveillance data, we expect that you can help setting up the systems and procedures that document how we comply with the latest regulatory expectations.

 

Open offices and high engagement

We are more than 90 colleagues in the Immunoassay R&D team distributed over two geographical sites (Denmark and Finland), and you will join the Danish part of the team in an open office environment. In addition, we have a software development team based in India. You will report to the Immunoassay System Manager, Mads Tarp, and can expect to build a strong professional and friendly relationship with the 10 other colleagues in his team.

Mads explains: “It’s a mixture of many different backgrounds ranging from chemists, laboratory technicians and systems engineers. Currently, we have two experts in the product risk area who can support and give input to you as they hand over the responsibility.”

 

Responsibilities summed up

• Leverage domain expertise to identify, document and control risks related to product design
• Work with multidisciplinary teams to drive down residual product risks to acceptable levels
• Ensure alignment between product risks, production process risks and other external interfaces
• Ensure that validation & verification plans address identified risk control measures
• Manage stakeholders and collaborate across our R&D sites in Denmark, Finland and India and Production sites in Denmark, Finland and Poland

 

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

Application deadline is Monday 18 March 2019. Please, start the application process by pressing "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 Hiring Manager, Mads Tarp at tel. + +45 3030 4827.

 

Qualifications 

We expect you to have a degree as an MS/PhD or equivalent in Engineering, Biological/Life Sciences, Chemistry or related field. An education within risk management will be an advantage. This combined with most of the following increases your chances of succeeding in this position: 

• Experience with product risk management, preferably within IVD or medical device development or pharmaceutical industry
• Experience with quality regulations and standards (EN/ISO 14971, 21 CFR 820, ISO 13485, ISO 62304 preferred)
• Ability to apply risk-based thinking to develop solutions that serve both business and compliance needs
• Effective communication and negotiation skills
• Technical and clinical insight
• Excellent attention to detail and accuracy, well organized and able to work independently and systematically in teams
• Experience with risk management techniques, e.g. FTA and FMEA

 

You are fluent in English and are capable of travelling up to 15% of your time. Any experience related to lifecycle management systems is an advantage.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. 

Organization:  Radiometer
Job Function:  Engineering
Primary Location:  EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule:  Full-time

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1321

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

source: DK-STAR