id: NDk5MzU5OCA3

reference: 4993598

documentId: 4993598

connectionPointId: 7

lastModificationDate: 1558528217450

stillingsbetegnelse:
Biomedical Engineer or similar for Software Risk and Usability Engineering – Graduate friendly job opportunity

jobbeskrivelse:

Description

Do you want to play a vital role in software development within Radiometer’s global R&D organization? Do you want a cross-functional role located in Copenhagen, where you secure the highest achievable quality and usability of our software and the related software documentation and system product level? 

If yes, then this job is your opportunity to combine your Medical Device experience and excellent communication skills to be part of a global organization where you can harvest the true potential of cross-site and cross-geographical collaboration. We believe we have a great team that can support your development and growth in this role.

Drive Risk Management through the Software Development Life Cycle

You act as a subject matter expert working closely with our embedded software architects and developers, our graphical user interface designers and our cross-functional human factors / usability engineering teams and System Product Risk Manager. Together you drive design control activities, e.g. software risk management, V&V and usability activities related to the entire software development life cycle. We organize our agile medical device software development around scrum teams based in DK and India.

Tasks include:

• Collaborate and contribute with current and upcoming new software quality processes and usability specialists in applying and maintaining our standard operating procedures, guidelines and document templates
• Driving improvements for our Standard Operating Procedures (SOPs) and processes related to standards and regulations 
• Utilize knowledge of risk management and usability engineering practices and regulations (e.g. ISO 14971 / TR 80002-1) & IEC 62366) to collaborate with device risk manager to analyze and document software risks and hazard related use scenario cases related to the overall product on system and component level
• Assist software teams and system usability & product risk specialists to conduct and document formative and summative usability studies 
• Provide input to  software verification and validation protocols involving usability aspects and implemented software risk control measures
• Supporting legacy R&D projects in terms of independent reviews including usability and software risk management assessments in achieving a risk-based approach.
• Train existing and newly on-boarded staff in design control, risk management and usability.
• Be subject matter expert in formal quality audits with focus on usability and software risk management.

In short – we are seeking a globally oriented person, who is proactive and have a good sense for collaboration and communication, without knowing the full picture. Someone who reaches out to relevant stakeholders in the organization; ensuring a broad basis for decisions – without losing track of the target.

Travel up to 15% of your time is to be expected.

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 Thursday 13 June, 2019. 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. You can also apply quick and simple through LinkedIn. We look forward to receiving your application.
For further information, please contact R&D Director, POC Management & IoT Software, Engineering, Morten Hastrup, +45 2070 3756 from week 22 due to travel activities. 

Qualifications 

We hope that you have experience or understanding related to documenting design quality and risk management within medical device software life cycle management. This combined with the following increases your chances of success in the job:  

• Engineering degree (bachelor or master) or similar theoretical background•

Good communication skills – verbally and written (e.g. by experience from communicating with Quality Assurance and Regulatory Affairs)

•Knowledge, experience and interest to work with medical devices is essential

• Ability to get up to speed with  the following standards and regulations: o Quality Management Systems - ISO 13485 & 21 CFR part 820o Risk Management – ISO 14971 and TR 80002-1o Usability Engineering – IEC 62366 and FDA guidance on Human Factors For Medical Deviceso Software Life Cycle Management – IEC 62304o FDA guidelines on usability engineering and 5.10K documentation

• Robust personality with a strong drive who thrives in a fast-paced and challenging work environment and can sustain having several tasks at once

• Fluent in spoken and written English is required. Danish or another Scandinavian language would be an asset. 

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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. 

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/C2143

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

source: DK-STAR