Usability + Design Control Specialist

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
You have a master’s or bachelor’s degree in engineering, pharmaceutics, life
strengthen our competences in R&D within developing products that follow the
science or similar with interest and experience within product development
regulatory requirements for medical equipment.
and/or Quality Assurance and Regulatory Affairs.
We are working in a challenging and developing environment with highly skilled and
motivated colleagues in multidisciplinary projects.
• Are passionate about working with leading tech. in product development
• Are prepared to learn about ultrasound technology
Maybe you are our next Usability & Design Control Specialist, if you have experience
• Have experience and are familiar with IEC62366-1: Usability Engineering and
from another similar position, have a can-do attitude, can embrace continuous
FDA guidance for Human Factors Engineering
improvements and if you enjoy interacting with a diverse set of stakeholders.
• Ideally have hands-on experience with usability testing, including preparing
protocols, executing usability tests and reporting.
The job:
• Are analytical, observant and can ask the right questions to get to essential
You will become part of a newly established Design Control & Usability Engineering
requirements
team in R&D, which has an important and central role in the development of the highly
• Experience with regulations, standards and guidelines within the medical
technical and innovative products, and here you will drive and be responsible for
device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30 is a
adherence to the usability processes.
plus.
Most of the daily work will be done in close cooperation with the Project Managers and
• Experience from facilitating product risk management activities and creating
the many highly skilled colleagues in R&D, but also with other stakeholders as, Quality
the risk management file is a plus
Assurance, Regulatory Affairs, Production, Marketing and more.
• 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
The degree of experience will define the seniority of the positions.
figure in the planning and follow up of all usability engineering (UE) activities. Here you
will:
Personal skills:
• Be responsible for UE from project beginning to end
You are a good communicator who thrives on having an active role in a cross
• Be a part of our cross functional teams and specialists e.g. in ultrasound and clinical
functional teamwork with many different colleagues. You are cooperative and
use of our products etc.
result oriented and value honest and direct communication as well as a positive
• Ensure that our user interface is documented and meets the relevant standards
and humorous outlook on life.
• Understand the preparation and maintenance of UE documentation
• Identify and analyze risks and user interactions
• Pro-active – You see solutions to problems
• Ensure that UE is an integrated part of Risk Management and Design Control
• A positive attitude with a helpful and curious mindset
• Support the continuous improvements of the standard operating procedures and
• Thrives with many different types of tasks.
instructions.
• Good communication- and co-operation skills
• Have e strong sense of quality and are highly organized
R&D Projects
Lisbeth Reindel
Manager, Design Control & Usability Engineering, R&D
Tlf: 60 216957
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..
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
- Rikke von Barm, Specification Engineer
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.
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.
“I chose to pursue a career in the
Research and Development
medtech industry because I want
BK Medical has development departments in Denmark and the US. The largest development team is based
to work at a place where both the
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
than 20 years. Together, we have completed 2 high technology projects for advanced ultrasound imaging.
strives for achieving better.”
We are currently part of a large-scale project with DTU, Danish hospital Rigshospitalet, and the University
- Rasmus H. Rossen,
of Copenhagen concerning extreme high-resolution ultrasound.
Senior Mechanical Engineer
Apply for the position:
[email protected]
We conduct interviews as we receive applications