Design Controls  Linda Kellberg

Linda Kellberg, Specialist, Product and Process Compliance

Linda has been a part of Innokas Medical’s Design Studio since Nov 2018. She works in Design Controls with multiple different customers, projects, and products. Linda is also involved in internal development and internal auditing, and participates in external audits as a representative from design and development supporting our Quality Team.

In my role I get to meddle with different projects, teams, customers, and devices, thus getting a unique insight of everything that is going on in-house and on the field of technology and medical devices in particular.

I have a Master’s Degree in Electrical Engineering from Tampere University of Technology. I initially applied to TUT only because I missed a place to study medical sciences – little did I know then that I would find my passion by studying technology.

 

I came to learn about medical devices and related technology through my main field of study: Biomedical Engineering and Biomedical Instrumentation. With a bit of hard work and a bit of luck I got a position as a Research Assistant in a project concentrating on productization and commercialization of a new medical device innovation. In that position I got a great opportunity to explore the world of medical devices, related regulations, and standards – and it soon became evident that that was what I really wanted to do and that was what I was going to be good at.

 

After graduation, I worked in a small software company developing standalone medical software products. From day one, I was learning about and working with/on Technical Documentation, Regulations, Standards, Quality Management Systems, device and system certifications, and the Regulatory Authorities and Notified Bodies. I got to wear at least 10 different “hats” including that of a technical writer’s, document controls’, and QA/RA manager’s.

 

After the summer 2018, I came across a job advert from Innokas Medical. They were looking for a Design Controls Specialist and I realized that they had just described ME in their ad. As working at Innokas had been my dream since the university I did not hesitate to try my luck. So here I am – and loving every minute of it!

 

In my role as a Design Controls Specialist at Innokas’ Design Studio I get to meddle with different projects, teams, customers, and devices, thus getting a unique insight of everything that is going on – in-house and on the field of technology and medical devices in particular. An essential part of my job is to stay tuned on current regulations and standards in general, and those related to Design Controls in particular. As important is me being able to apply my knowledge and experience, including these regulations, standards and controls to our customer projects and to our costomer’s projects – to medical device design and development and everything that comes with it.

 

I have always been keen to learn and to challenge myself. Accordingly, I see Innokas as an exceptional employer in the field of medical device R&D enabling me to grow as a professional in a versatile environment and as a part of a multidiciplinary team of rock solid experts from different competence areas (software, hardware, mechanics, usability, risk management, etc.). The thing I enjoy the most is the support our team provides each other and the fact that we are all aiming for the same goal!