Software Design Quality and Usability Engineer-MED001440

Description

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


Drive design quality for 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. Together you drive design quality 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 with software quality process and usability specialists in applying and maintaining our standard operating procedures, guidelines and document templates• 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 use related risks

• Participate in cross-functional activities to develop unambiguous and feasible software requirements that support market needs as stated by product marketing

• Ensure that new software development as well as software maintenance activities are executed and documented according to applicable quality regulations – including design controls

• Assist software teams and device usability specialists to conduct and document formative usability studies 

• Take part in creating software verification and validation protocols including usability aspects.

• Oversee software unit and systems level test execution and analysis for standards and products requirements compliance

• Apply your working knowledge of IEC 62304 to direct  the software teams in terms of life cycle management and related documentation

• Supporting legacy R&D projects in terms of independent reviews including usability assessments

• Train existing and newly on-boarded staff in design control, risk management, software life cycle management and usability.

• Be subject matter expert in formal quality audits with focus on usability and software life cycle management


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 19 February 2018. 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 Software Development Manager, Allan Westphal (+45 20721584) or Head of ABL Software, Henrik Pallisgaard (+45 29444266).
 

 

QualificationsWe hope that you have experience 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 and experience 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 62304

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


In short – we are seeking a proactive and extrovert globally oriented person who, without knowing the full picture, 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. 

 

Danaher Corporation OverviewDanaher 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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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:  RadiometerJob Function:  EngineeringPrimary Location:  EMEA-Western Europe-Denmark-Hovedstaden-BrønshøjSchedule:  Full-time


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