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Medical Device Engineer, Product Verification & Validation Specialist in Brønshøj, Denmark at Radiometer

Date Posted: 3/12/2019

Job Snapshot

Job Description

Job ID: MED001708

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 3200 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 verification and product validation activities from the first concept to the final design verification and design validation.

You are motivated by working with Medical Device and In Vitro Diagnostic (IVD) Medical Device development with the mission to provide safe and effective, easy to use products that help caregivers make diagnostic decisions that save lives.

You want to be part of a new agile matrix organization that strives to deliver the right product in the right quality first time. If this appeals to you, we encourage you to read more below.

Introducing the R&D New Product Development, Verification & Validation team

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 of Verification & Validation, Pernille Dybendal Hammelsvang.

The highly skilled and experienced team consists of three lab technicians and five academics and is responsible for:

• Planning, coordinating and ensuring execution of design verification deliverables with the right quality.

• Contributing to the execution of design validation activities such as performance testing, simulated use testing and clinical studies and recapitulating this in the technical file / Design History File

• Giving input when setting product requirements and defining acceptance criteria with respect to mechanical, electronical and chemical (including blood parameter) performance

• Defining and documenting how to verify and validate product requirements

• Planning and conducting explorative & reliability testing

• Creating high-quality verification and validation documentation under design control supporting regulatory registrations worldwide

• Transfer of the final verified and validated product into to commercialization

The position

Since we have recently established a matrix organization, and there are several projects to support simultaneously, you can expect exciting and dynamic days at work.

The position is an opportunity to contribute to the development of Medical Device and In Vitro Diagnostic (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.

For this position, the main project will initially be around a complex In Vitro Diagnostic (IVD) Medical Device system.

Your responsibilities

You can look forward to following:

• Utilize mechanical and electronic design experience and technical knowhow to act as a trusted sparring opponent ensuring development of reliable high-quality devices

• Proactively seek out and encourage stakeholder interaction to ensure transparent alignment of verification and validation activities within the project and the organization

• Plan, coordinate and ensure execution of Product Verification & Product 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 supporting regulatory registrations worldwide.

You are fluent in English – spoken and written and are available to travel around 15 days per year. Solid knowledge of statistics including ANOVA and hands-on experience with SAS JMP (or similar) and scripting is an advantage.

Application deadline

Application deadline is Monday 8 April 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 41179 770.

Job Requirements



Qualifications

We expect you to have a master’s degree within mechanical/electronical engineering, science or similar (minimum B.SC) with 5+ years of experience within the Medical Device / In Vitro Diagnostic (IVD) Medical Device business.

This combined with most of the following competencies increases your chances of success in the job:

• Experience with planning, coordinating, executing and documenting Design verification & Design validation within Medical Devices and In Vitro Diagnostic (IVD) Medical Devices applying a thoughtful risk-based approach

• Solid knowledge of ISO 13485, 21CFR part820, MDR and IVDR legislation

• Demonstrated experience with ISO 80369 or IEC 60601 series

• Preferably hands-on experience with mechatronic engineering and reliability testing

• Broad knowledge of materials specifically plastics and metals

• Professional insight into mechanical and electronic manufacturing processes

• Proven record within generation of high-quality verification and validation documentation under design control supporting regulatory registrations worldwide

You are fluent in English – spoken and written and are available to travel around 15 days per year. Solid knowledge of statistics including ANOVA and hands-on experience with SAS JMP (or similar) and scripting 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.