Danaher Corporation Senior Design Control Process Specialist in Bronshoj, Denmark
Your background and experience are probably from Research & Development (R&D) or Regulatory Affairs/Quality Assurance (RA/QA) within the Medical Devices industry. You have a desire to impact the way we work with Design Control processes across our products and business areas – and want to work cross-functionally. Does this sound like you? Then we have the job for you!
This position is attractive because it offers an outstanding possibility to work across all Radiometer’s product platforms. From a strategic Design Control point of view, you will build, optimize, and maintain key tools & processes leading to our world-class IVDR and MDR equipment.
As a Design Control Process Specialist, the role is a part of the New Product Development management team. This role will work together with a wide range of stakeholders within R&D, RA/QA, and Operations both locally and internationally and across product platforms. The main focus is Design Control (DC) for the new development of new products and R&D product maintenance.
By working together with partners, we are able to set the right level of ambition when it comes to securing compliance as well as lean & effective execution of Radiometers Design Control processes.
Master, Bachelor or similar in a technical area, e.g., Engineering, Science, Pharmacy or similar.
5 years’ experience with Medical Device product development and/or maintenance.
Proven experience with creating and reviewing of complex Design Control documentation.
Experience with creation/deployment of Medical Device development processes and SOPs.
Have participated in FDA or Notifying Body inspections/audits.
In-depth and up-to-date understanding of requirements in regulations like 21CFR820.30, ISO13485, ISO14971, IEC62366, IEC62304, and the new EU IVD/MD regulation.
Strong cross-functional collaboration skills (incl. Production, RA/QA and R&D).
Strong communication skills and ability to work optimally in a global setup.
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgment 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 helping realize life’s potential.
An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad we have hardworking colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer 'freedom with responsibility', flexibility, opportunities for training and career development, and a plethora of staff benefits.
We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. Any important questions regarding the position can be directed to the Talent Acquisition Partner David Lyngh at email@example.com. #LI-DA1
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .