Design Control Specialist

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danish or english to:
[email protected]
Mark the application:
“Design Control Specialist”
We hold interviews ongoing
Design Control Specialist, R&D
Would you like to be part of an international and innovative working environment,
where some of the worlds best ultrasound systems are developed?
Design Control Specialist in R&D
For our Headquarter in Herlev, Copenhagen, we are looking for new Qualifications:
colleagues to strengthen our competences in R&D within developing You have a master’s or bachelor’s degree in engineering, pharmaceutics, life
products that follow the regulatory requirements for medical equipment. science or similar with interest and experience within product development
and/or Quality Assurance and Regulatory Affairs.
We are working in a challenging and developing environment with highly
• Passionate about working with leading technological product development
skilled and motivated colleagues in multidisciplinary projects.
• Are prepared to learn about ultrasound technology
• Experience with regulations, standards and guidelines within the medical
Maybe you are our next Design Control Specialist, if you have
device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30 is a
experience from another similar position, have a can-do attitude, can
plus.
embrace continuous improvements and if you enjoy interacting with a
• Experience from driving and documenting design control activities such as
diverse set of stakeholders.
requirement engineering, design verification and facilitating design reviews.
The job:
• Experience from facilitating product risk management activities and creating
You will become part of a newly established Design Control & Usability
the risk management file.
Engineering team in R&D, which has an important and central role in the
• Are fluent in English, spoken and written.
development of the highly technical and innovative products, and here
you will drive and be responsible for adherence to the design control
The degree of experience will define the seniority of the positions.
processes.
Most of the daily work will be done in close cooperation with the Project
Personal skills:
Managers and the many highly skilled colleagues in R&D, but also with
You are a good communicator who thrives on having an active role in a cross
other stakeholders as, Quality Assurance, Regulatory Affairs,
functional teamwork with many different colleagues. You are cooperative and
Production, Marketing and more.
result oriented and value honest and direct communication as well as a positive
and humorous outlook on life.
Primary tasks:
• Pro-active – You see solutions to problems
Your job will be to work in in a cross functional product development
• A positive attitude with a helpful and curious mindset
team as a key figure in the planning and follow up of all design control
• Thrives with many different types of tasks.
activities. Here you will:
• Good communication- and co-operation skills
• Drive and document design control activities in various R&D projects
• Have e strong sense of quality and are highly organized
• Provide relevant input to the project planning activities
• Ensure a constant updated design document transparence
• Ensure the quality of the Technical File documentation
• Support the continuous improvements of the standard operating
procedures and instructions.
R&D Projects
Lisbeth Reindel
Manager Design Control & Usability Engineering
Tlf: 6021 6957
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 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
Boston and Herlev.
All project documentation is prepared in English..
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 surgeons make decisions that can improve outcomes for
patients.
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 one of our latest
developments. 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 and the US. The largest development team is based in Denmark with approximately 100
employees, while there are 11 employees in State College, Pennsylvania. 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 670 employees, 210 in Herlev. In 2020, we booked revenue of USD 163 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:
“Design Control Specialist”
We conduct interviews as we receive applications