Design Verification & Design Validation Specialist in Brønshøj, Denmark at Radiometer

Date Posted: 11/8/2019

Job Snapshot

Job Description

Job ID: MED001865

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link: Link of YouTube video
Our people
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3800 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

Coming from the Medical Device industry, you understand the importance of product design verification and design validation activities from the first concept to the final verification and validation. 

Are you motivated by working with In Vitro Diagnostic (IVD) and device development within the medico industry? Look no further! We have a mission to provide safe and effective, easy to use products that help caregivers make diagnostic decisions that save lives. 
If it appeals to you to work in an agile matrix organization that strives to deliver the right product in the right quality first time then you are the right candidate for us.

Introducing the colleagues
You will be a part of the Verification & Validation Team in the R&D New Product Development section, reporting to the R&D Senior Manager Pernille Dybendal Hammelsvang. 
We are a highly skilled and experienced team consisting of three lab technicians and five academics responsible for:
• Giving input when setting product requirements and defining acceptance criteria for mechanical, electronic and chemical (including blood parameter) performance
• Defining and documenting how to verify and validate 
• Planning, coordinating and ensuring execution of design verification and design validation deliverables
• Creating high-quality documentation within verification and validation under design control supporting regulatory registrations 
• Contributing to the execution of design validation activities such as performance testing, simulated use testing, and clinical studies 
• Transfer of the final verified and validated product to commercialization

The R&D Specialist position
We are operating in a matrix organization running several projects simultaneously, which means you can expect exciting and dynamic days at work.
The position is an opportunity to contribute to the development of IVD Medical Device systems as they move from concept into design- verification and validation through clinical studies, global regulatory submissions & registrations, and transfer to commercialization. 

Your responsibility
You can look forward to:
• Utilize mechanical and electronic design experience and technical know-how ensuring the development of reliable high-quality devices
• Actively seek out and encourage stakeholder interaction to ensure transparent alignment of design verification and validation activities within both project and organization
• Plan, coordinate and ensure execution of verification & validation activities in early as well as late product development stages in close cooperation and alignment with both internal and external stakeholders
• Generate high-quality verification and validation documentation under design control 

Application deadline
Application deadline is Wednesday 20 November 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. We look forward to receiving your application.

For further information, please contact R&D Senior Manager, Verification & Validation, Pernille Dybendal Hammelsvang at tel. +45 4117 9770.

Job Requirements



Qualifications

We expect you to have a master’s degree within engineering, science or similar (minimum B.Sc.) with 5+ years of experience within IVD or Medical Device business.
This combined with most of the following proficiencies increases your chances of success in the job:
• Experience with planning, coordinating, executing and documenting Design verification & Design validation 
• Proven record within a generation of high-quality design verification and validation documentation under design control 
• Solid knowledge of ISO 13485, 21CFR part820, MDR and IVDR legislation
• Experience with mechatronic engineering and reliability testing
You are proficient in English – spoken and written and are available to travel around 15 days per year. 
Proven knowledge of statistics including ANOVA and hands-on experience with SAS JMP (or similar) and scripting is an advantage. Experience and knowledge of CLSI guidance is a clear 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, 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.