Jon Berg Email & Phone Number

Lund, Skåne, Sverige

Lund, Skåne, Sverige

Hörby, Skåne Län, Sverige

- Product owner for NPD and SE- Implementation of MDR, TD- Voice rehabilitation- Pulmonary rehabilitation- Injection molding- Active devices- Implantable devices

Malmö, Skåne, Sverige

As Manager of Development my main responsibility is to lead development projects within medical cooling systems. The projects starts with proof of principle and ends with the complete market launch. The team includes several medical experts, QA experts, business management and highly skilled project leaders and engineers. Our products are tested according to 60601-1, including safety, EMC, PEMS, usability and the alarm standard. As manager of QA/RA my main focus was to develop and maintain BrainCool’s full ISO 13485 system and Japan GMP system. Obtain EC certificate for our class IIa and IIb products, obtain certificate of registration for our single use Class I products and submit our first 510k.

Included in the COOs responsibilities are R&D, Manufacturing, Purchasing and Quality Assurance. Dignitana business model is to work in close contact with sub-contractors for manufacturing and development. Dignitanas market is divided between several distributers that promote, sell and service the medical device products. My team is a mix of Dignitana employees, sub-contractors and distributers from several parts of the world

New Product Development. The project was intended to develop and launch a new platform for Gambros water treatment devices. The project team is x-functional and includes R&D, Operation, Purchasing, Regulatory, Quality Assurance, Sales and Marketing.

As Group Manager I had responsibility for 14 mechanical engineers and also Gambros mech. consultants. Depending on the engineer’s background and experience they were placed in different development projects throughout Gambro . This role also included the responsibility for the engineering tools, Pro-E, AutoCAD and PDM-Link.

Product Lifecycle Engineering Manager for Gambros Water Treatment devices. In this role I had the responsibility for all sustain engineering of the platform. The project team included between 15-20 engineers. Full budget responsibility and Gambro’s ”Single point of contact” for this platform.

Project Leader for sustaining engineering of one of Gambros products. Managing 1-3 engineers and with responsibility for budgeting

Helsingborg, Sverige

Assignment: Haldex in Landskrona: Was a part of the pilot production of the Haldex coupling. Responsible for assembly instructions. Tetra Pak in Lund:” Department Food and Beverage”. Mechanical designs in AutoCAD Besam in Landskrona: New product development of door openers. Mechanical design in Pro-E.