Design Control Specialist

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[email protected]
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“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
skilled and motivated colleagues in multidisciplinary projects.
• Passionate about working with leading technological product development
• Are prepared to learn about ultrasound technology
Maybe you are our next Design Control Specialist, if you have
• Experience with regulations, standards and guidelines within the medical
experience from another similar position, have a can-do attitude, can
device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30 is a
embrace continuous improvements and if you enjoy interacting with a
plus.
diverse set of stakeholders.
• Experience from driving and documenting design control activities such as
The job:
requirement engineering, design verification and facilitating design reviews.
You will become part of a newly established Design Control & Usability
• Experience from facilitating product risk management activities and creating
Engineering team in R&D, which has an important and central role in the
the risk management file.
development of the highly technical and innovative products, and here
• Are fluent in English, spoken and written.
you will drive and be responsible for adherence to the design control
processes.
The degree of experience will define the seniority of the positions.
Most of the daily work will be done in close cooperation with the Project
Managers and the many highly skilled colleagues in R&D, but also with
Personal skills:
other stakeholders as, Quality Assurance, Regulatory Affairs,
You are a good communicator who thrives on having an active role in a cross
Production, Marketing and more.
functional teamwork with many different colleagues. You are cooperative and
result oriented and value honest and direct communication as well as a positive
Primary tasks:
and humorous outlook on life.
Your job will be to work in in a cross functional product development
team as a key figure in the planning and follow up of all design control
• Pro-active – You see solutions to problems
activities. Here you will:
• A positive attitude with a helpful and curious mindset
• Thrives with many different types of tasks.
• Drive and document design control activities in various R&D projects
• Good communication- and co-operation skills
• Provide relevant input to the project planning activities
• Have e strong sense of quality and are highly organized
• 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, 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 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 produkter
Vi søger medarbejdere, der er lige så dynamiske og motiverede, som
vi er. Medarbejdere, der er engagerede i udvikling af produkter, som kan
hjælpe læger med at tage beslutninger, der forbedrer patienters
livskvalitet.
Nedenfor ses nogle af de mange produkter, vi er stolte over at have
udviklet.
Vores produkter er designet
til ultralydsundersøgelser
på følgende områder:
Kirurgi
Urologi
Bækkenbund
Kolorektalt
Robotic Drop-In ultralydstransduceren bruges
under kirurgiske indgreb til at visualisere
organer. Den føres ind i abdomen gennem en
trokar og kan styres af en robot.
Ultralydsbillederne hjælper kirurgen med at
tage beslutninger under indgreb.
bkSpecto er vores nyeste udvikling.
Denne unikke skanner er kendetegnet
ved meget høj billedkvalitet og et
glasinterface, som er nemt at betjene.
BK Medical
Intraoperativ ultralyd
BK Medical er engageret i af at designe ultralydssystemer, der hjælper kirurger med at skanne, styre, foretage indgreb og navigere inde i
menneskekroppen. Vores kunder er kirurger og spænder fra HPB-kirurger, neurokirurger og robotassisterede kirurger til urologer, kolorektale kirurger
med flere.
Vores mission er at muliggøre intraoperativ vejledning i realtid under kirurgiske indgreb ved at give kirurger de nødvendige oplysninger til straks at
træffe kritiske beslutninger. Vores produkter er designet og tilpasset til kirurgiske indgreb for at hjælpe kirurger med at spare tid og opnå resultater.
BK Medical er markedsledende og arbejder tæt sammen med eksperter og universiteter for at levere de bedste løsninger til kliniske udfordringer.
Forskning og udvikling
BK Medical har udviklingsafdelinger i Danmark og USA. Det største udviklingsteam har til huse i Danmark og består af 88 medarbejdere, mens der er
15 medarbejdere i Stage College i Pennsylvania. Vi udvikler inden for software, hardware, mekanik, signalbehandling og avancerede algoritmer.
Når det gælder forskning, har vi samarbejdet med Danmarks Tekniske Universitet (DTU) i mere end 20 år. Sammen har vi gennemført 2
højteknologiske projekter til avanceret ultralydsskanning. Vi deltager for øjeblikket i et storstilet projekt med DTU, Rigshospitalet og Københavns
Universitet om ultralyd med ekstrem høj opløsning.
Global organisation
BK Medical er en international virksomhed med salgskontorer over hele verden og europæisk hovedkontor i Herlev tæt på København. Vi har omkring
650 ansatte, heraf 170 i Herlev. I 2020 omsatte vi for 163 millioner USD.
Hos BK Medical støtter vi , at vores medarbejdere udvikler deres kompetencer og viden. Vi har en professionel og uformel organisation med fleksible
arbejdsvilkår og en flad organisationsstruktur.
Vi er effektive og fører vores ideer ud i livet i form af stærke produkter – disse ingredienser gør BK Medical til en spændende og udviklingsorienteret
arbejdsplads.
Vi ser frem til at byde dig velkommen i et team, der gør en forskel – en forskel i livskvalitet.
Søg stillingen på:
[email protected]
Mærk ansøgningen:
“Senior Usability Engineer”
Vi holder løbende samtaler