Marta Björnsdóttir

Lead Technical Product Manager at Integrum AB
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Contact Information
Location
Gothenburg, Vastra Gotaland County, Sweden, SE
Languages
  • Icelandic Native or bilingual proficiency
  • English Professional working proficiency
  • Swedish Professional working proficiency
  • Danish Elementary proficiency
  • German Elementary proficiency

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Experience

    • Sweden
    • Medical Device
    • 1 - 100 Employee
    • Lead Technical Product Manager
      • Jan 2022 - Present

      Manager for the Technical Product Manager Group.Responsible for the full OPRA Implant System, including implants and prosthetic components as well as surgical instruments. Responsibilities include technical file management and regulatory compliance towards MDR and FDA, risk management, monitoring of post market surveillance activities and defining the product portfolio.

    • Technical Product Manager
      • Apr 2021 - Feb 2022

      Technical Product Manager for orthopedic implants and surgical instruments.Responsibilities include technical file management, risk management and monitoring of post market surveillance activities.

    • OPRA Development, Lead Engineer
      • Jul 2017 - Nov 2021

      I continued with activities described in the previous description.During my time in the new role the development team has released a new surgical instrument and optimized components in our implant system. I have also explored and evaluated new technologies to be implemented in our product assortment and been in contact with our costumers and users for feedback for continuous improvement of our products.I have supported with answers to technical questions in audits and reports for FDA and notified bodies in Europe.I am also a project manager of a development project. Where, in addition to being responsible for delivering the project within allocated time and resources, I am responsible for the mechanical design, verification and validation activities, the Design History File, Risk Analysis (DFMEA, PFMEA) and the design transfer to the suppliers. Show less

    • R&D Engineer
      • Feb 2015 - Jun 2017

      I worked with development of the full product range that includes OPRA Implant System, surgical instruments and prosthetic devices.During this period we launched a new version of the OPRA Implant System where I was responsible for planning and executing all mechanical verification tests. I was responsible for all other mechanical tests performed on the full product assortment. I performed CAD design updates and technical drawing updates as well as communicating to suppliers about updates and manufacturing specifications. Moreover I was responsible for other development tasks such as updating technical files (DHF) and actively participating in Risk Analysis meetings. I also gave technical support to our customer support as well as root cause analysis in post market activities.Furthermore I supported the research team with the development of mechanical components and surgical techniques for the e-OPRA system. Show less

    • Sweden
    • Higher Education
    • 700 & Above Employee
    • Research Engineer
      • Sep 2014 - Dec 2014

      Helped to develop a musculoskeletal gait analysis model to analyze gait patterns for children with cerebral palsy. Helped to develop a musculoskeletal gait analysis model to analyze gait patterns for children with cerebral palsy.

    • School Principal and Manager
      • Jun 2013 - Aug 2013

      Vífill is a Scout Association in Iceland has offered a Summer Outdoor-School for children between 5 and 12 years old that seek summer adventures for the last 20 years. The job included being responsible for 40-60 children each week and managing over 40 employees from the age of 18 to 23, organizing daily activities, communicating with parents, purchasing, documenting weekly schedules, making employee working schedule and more. Typical activities planned for each week were e.g. kayak rowing, bicycle tours, rock climbing and camping http://www.vifill.is/ Show less

    • Singapore
    • Construction
    • 1 - 100 Employee
    • Engineer, R&D Department - Prosthetic Feet Group
      • May 2010 - Aug 2012

      I was involved in all stages of product developement of prosthetic feet, from conceptual design to a finished product. This included - making 3D CAD designs and drawings for production - building prototypes - constructing mechanical tests for prototypes - testing the prototypes on users and analyzing their feedback for further improvements of the product. I was mostly involved in designing feet for people with typically low activity levels. That project required travelling to Össur’s facilities in Mexico and California to develop production methods for a polyurethane part and making prototypes which were then tested on users. I gained experience with carbon fiber/epoxy composites, polyurethane and production methods I developed good skills in SolidWorks making 3D CAD designs and hands on skills in prototype making. I also gained valuable knowledge and experience learning about the different needs of different types of amputees, user testing, patient communication and gait analysis. Show less

    • Accountant - Summer job
      • May 2006 - Aug 2009

      General book keeping work e.g. regarding cost and sales invoices. General book keeping work e.g. regarding cost and sales invoices.

    • Wholesale Building Materials
    • 1 - 100 Employee
    • Sales Assistant, Cashier
      • Jun 2002 - May 2007

      Byko is a construction product store in Iceland. I worked there every summer from 2002 to 2006 and as well with school as a part time job from 2002 to 2007. My responsibilites included general assistance and managing the information desk and cashiers. Byko is a construction product store in Iceland. I worked there every summer from 2002 to 2006 and as well with school as a part time job from 2002 to 2007. My responsibilites included general assistance and managing the information desk and cashiers.

Education

  • KTH Royal Institute of Technology
    Master of Science (MSc), Engineering Mechanics
    2012 - 2014
  • Háskóli Íslands
    BSc, Mechanical engineering
    2007 - 2010
  • Commercial College of Iceland
    College, Economics
    2003 - 2007

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