Validation Specialist

Send your application in English to:
[email protected]
Mark the application:
“Validation Specialist”
We conduct interviews as we receive
applications
Validation Specialist of
Disinfection and Sterilizations
Methods for Medical Device
Do you have experience with the validation of disinfection and sterilization
methods for medical devices?
And do you work well within defined sets of regulations, quality standards and
would you like to advise hospitals and clinics worldwide?
If yes, then apply now and join the BK Medical R&D organization
Validation Specialist
We are looking for a Validation Specialist to strengthen our capabilities
Qualifications:
within disinfection and sterilization. Apply now and join the BK Medical
Your educational background may be varied, as the
R&D organization.
job includes evaluation of chemical compatibility of
You will join a dynamic, international and innovative environment, where
materials, microbiological assays of efficacy, and
highly skilled professionals work closely together to develop next
knowledge of material science. We imagine that you
generation medical devices to improve clinical results and enhance
hold a master's degree in Pharmacy, Chemical
patient outcomes.
Engineer or other relevant background
You have experience with chemical disinfection and
sterilization of medical devices, or with products /
The position:
methods used for general reprocessing of medical
As a Validation Specialist, you will be part of a team that has global
devices
collaboration with manufacturing in the USA, cooperation with external
You have experience of working in regulated areas,
laboratories and partners worldwide. The team is responsible for
such as in medical device or in the pharmaceutical
introducing and sustaining approved disinfection and sterilization
industry
methods across our product portfolio. We work with R&D, QA, RA,
Preferably experience with project management of
service, sales and marketing to support our customers with the latest
smaller projects
guidance for all our products.
You are fluent in English, both in writing and speaking
The requirements of new disinfection and sterilization methods for
Personality:
medical equipment are growing rapidly and at the same time, regulatory
requirements are increasing worldwide. Therefore, we are looking You have a collaborative mind-set and use your great
forward to welcoming you to our team. interpersonal skills to communicate openly
You are a good coordinator who can deliver
You will participate in development projects with planning, coordination
Thrives in an environment with new developments and
of analyzes, tests, implementation and application of methods for
new challenges
medical ultrasound products. You will also support continued testing and
Committed, structured and solution-oriented
research to support existing products. Additionally, you must stay up to
You thrive on being systematic, thorough and detail-
date with customer needs, trends and relevant legislation worldwide, to
oriented while being able to see the bigger picture
ensure that BK Medical follows developments in the area and make safe
Ability to influence and respond to stakeholders across
compatible products for the wide range of our customers.
the organization and facilitate meetings and workshops
in order to reach decisions and ensure progress
Quality & Regulatory
Jens Weirsøe
Vice President Quality & Regulatory
+45 4452 8195
We are part of a global organization with European headquarters
in Herlev, Denmark.
We see the potential of a large market in our niche in ultrasound
diagnostics. At the same time, there are more and more
requirements from authorities that we must meet in order to sell
our products all over the world.
We are setting up a department to work with Materials Science in
order to meet the requirements of both customers and
authorities.
We work globally with production and development in both
Denmark and in the USA and with sales globally. We are a group
of specialists who each contribute at a high professional level.
We are pragmatic and solution-oriented and work inter-
organizationally to offer the best ultrasound instruments in the
world.
….. more about the job
Ask a colleague about BK Medical
Do you want to be successful in your job as a Validation
At BK Medical, we are - in line with the company's
Specialist:
values - very open about the company's qualities
as a workplace. Therefore, we encourage
applicants to contact an employee from the
You thrive on project work
department.
As a Validation Specialist, you have abundant opportunity to
influence design and thereby can you influence the output of the
development projects.
Jasmina Visholm
Reprocessing Specialist
You make decisions
+45 2728 4829
We have an informal tone and a flat decision-making structure.
You can have a significant influence on planning and organizing
daily work.
You think ahead
It is natural for you to think in long term solutions. You know how
to estimate the time spent on the tasks covered.
You take responsibility
Once the solution is found, you have the responsibility to
implement it. You follow the task to the end so that it can be
completed without loose ends.
You deliver solutions and quality
You will find pragmatic solutions that comply with all applicable
rules for our products.
Innovative Products
We are looking for employees who are as driven and
motivated as we are. Employees who are passionate
about developing products that can help doctors make
decisions to improve patients’ quality of life
Below are some of the many products we are proud to
have developed.
Our products are
designed for ultrasound
examinations in:
Surgery
Urology
Pelvic Floor
Colorectal
The Robotic Drop-In ultrasound transducer is
used during surgical procedures to visualize
organs. It is inserted through a trocar in the
abdomen and can be controlled by a robot.
The ultrasound images help the surgeon in
decision making during surgery.
The bkSpecto is our latest
development. This unique scanner
has very high image quality as well
as an easy-to-use glass interface
BK Medical
Intraoperative Ultrasound
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons
are our customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately
make critical decisions. Our products are designed and customized for surgical procedures, to help surgeons save time and get results.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical challenges.
Research and Development
BK Medical has development departments in Denmark, the US, and Canada. The largest development team is based in Denmark with approximately
80 employees, while there are 24 employees in State College, Pennsylvania, and 11 in Vancouver, Canada. We do development in software, hardware,
mechanics, signal processing, and advanced algorithms.
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more than 20 years. Together, we have
completed 2 high technology projects for advanced ultrasound imaging. We are currently part of a large-scale project with DTU, Danish hospital
Rigshospitalet, and the University of Copenhagen concerning extreme high-resolution ultrasound.
Global Organization
BK Medical is an international company with sales offices all over the world, and European headquarters in Herlev, Copenhagen. We have
approximately 600 employees, 150 in Herlev. In 2019, we booked revenue of USD 175 million.
At BK Medical, we support employees in developing their skills and expertise. We have a professional and informal organization
with flexible working conditions and a flat organizational structure.
We are effective and can execute our ideas into strong products – these ingredients make BK Medical an exciting and development-oriented workplace.
We look forward to welcoming you to a team that makes a difference – a difference to quality of life.
Apply for the position:
[email protected]
Mark the application:
“Validation Specialist”
We conduct interviews as we receive applications