R&D Specialist, Usability & Design Control

Send your application in Danish or
English to:
[email protected]
Mark the application:
“R&D Specialist, Usability & Design
Control”
We conduct interviews as we receive
applications
R&D Specialist,
Usability & Design Control
Would you like to be part of an international and innovative
working environment, where some of the worlds best
ultrasound systems are developed?
.
R&D Specialist, Usability & Design Control
Qualifications
For our Headquarter in Herlev, Copenhagen, we are looking for new colleagues to strengthen our
competences in R&D within developing products that follow the regulatory requirements for
You have a master’s or bachelor’s degree in engineering, pharmaceutics, life science or similar
medical equipment.
with interest and experience within product development and/or Quality Assurance and
We are working in a challenging and developing environment with highly skilled and motivated Regulatory Affairs.
colleagues in multidisciplinary projects.
• Are passionate about working with leading tech. in product development
Maybe you are our next Usability & Design Control Specialist, if you have experience from
• Are prepared to learn about ultrasound technology
another similar position, have a can-do attitude, can embrace continuous improvements and if
you enjoy interacting with a diverse set of stakeholders.
• Have experience and are familiar with IEC62366-1: Usability Engineering and FDA guidance
for Human Factors Engineering
The job
• Ideally have hands-on experience with usability testing, including preparing protocols,
executing usability tests and reporting.
You will become part of a newly established Design Control & Usability Engineering team in R&D,
• Are analytical, observant and can ask the right questions to get to essential requirements
which has an important and central role in the development of the highly technical and innovative
products, and here you will drive and be responsible for adherence to the usability processes.
• Experience with regulations, standards and guidelines within the medical device area e.g.,
Most of the daily work will be done in close cooperation with the Project Managers and the many MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30 is a plus.
highly skilled colleagues in R&D, but also with other stakeholders as, Quality Assurance,
• Experience from facilitating product risk management activities and creating the risk
Regulatory Affairs, Production, Marketing and more.
management file is a plus
• Can speak and write Danish and English at a high technical level
Primary tasks
Your job will be to work in in a cross functional product development team as a key figure in the
The degree of experience will define the seniority of the positions.
planning and follow up of all usability engineering (UE) activities. Here you will:
• Be responsible for UE from project beginning to end
Personal skills:
• Be a part of our cross functional teams and specialists e.g., in ultrasound and clinical use of our
You are a good communicator who thrives on having an active role in a cross functional
products etc.
teamwork with many different colleagues. You are cooperative and result oriented and value
• Ensure that our user interface is documented and meets the relevant standards
honest and direct communication as well as a positive and humorous outlook on life.
• Understand the preparation and maintenance of UE documentation
• Identify and analyze risks and user interactions
• Ensure that UE is an integrated part of Risk Management and Design Control
• Pro-active – You see solutions to problems
• Support the continuous improvements of the standard operating procedures and instructions.
• A positive attitude with a helpful and curious mindset
• Thrives with many different types of tasks.
• Good communication- and co-operation skills
• Have e strong sense of quality and are highly organized
R&D Projects
BK Medical’s R&D today consists of approx. 100 technical specialists and managers
distributed between our main R&D center in Herlev and our transducer development
center in State College, Pennsylvania US. R&D is divided into 8 departments, where
the newly established Design Control & Usability Engineering is among
R&D's employees all have a technical background and reflect the broad cultural
diversity that is a natural part of a global company. We work in a project environment
where the individual projects are managed by a project manager who has extensive
experience in developing BK Medicals products. The projects are managed in cross
functional product development teams, and it is in these teams that our new Usability
& Design Control Specialist will be a key figure.
Our development projects embrace broadly e.g., optimizing the image quality of
existing transducers, new innovative transducers, SW for our ultrasound platform,
upgrading existing scanners with new functionality as well as new scanners and
platforms. In addition, we spend a large part of our time on Research in ultrasound.
The project work is carried out in teams, typically with resources from the global BK
Medical organization - BK Medical in Herlev, BK Medical in State College in
Pennsylvania and BK Medical in Boston. As a natural part of the development of
medico technical products, we carry out our projects based on a well-developed and
mature development model. Planning and execution make extensive use of visual
project management according to the Agile principles.
All production of transducers takes place in Pennsylvania and production of systems
in Herlev.
All project documentation is prepared in English.
You are welcome to contact Lisbeth Reindel, Manager Usability and Design Control
by phone +45 6021 6957 or [email protected]
BK Products Guides Procedures for the Surgeon
Urologist Neurosurgeon HPB Surgeon
Colorectal Surgeon Robotic Surgeon Adjacent Market Users
BK Medical
“By working within these
Global Organization
specialties, I realized that I could
BK Medical is an international company with sales offices all over the world, and European headquarters in
provide or improve the health care
Herlev, Copenhagen.
system that way.”
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
- Rikke von Barm, Specification Engineer
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.
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.
Now, BK Medical is advancing its mission with GE Healthcare. Together, we will reach more customers and
continue to empower surgeons to make critical decisions that allow for better care, faster procedures, and
reduced complications.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical
“I chose to pursue a career in the
challenges.
medtech industry because I want
Research and Development
to work at a place where both the
BK Medical has development departments in Denmark and the US. The largest development team is based
in Denmark. We develop software, hardware, mechanics, signal processing, and advanced algorithms.
company and the colleges always
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more
strives for achieving better.”
than 20 years. Together, we have completed 2 high technology projects for advanced ultrasound imaging.
- Rasmus H. Rossen,
We are currently part of a large-scale project with DTU, Danish hospital Rigshospitalet, and the University
Senior Mechanical Engineer
of Copenhagen concerning extreme high-resolution ultrasound.
Apply for the position:
[email protected]
Mark the application:
“R&D Specialist, Usability & Design Control”
We conduct interviews as we receive applications