Systems Engineer

Cochlear Bone Anchored Solutions AB is a medical device company and the world leader within bone anchored hearing solutions. Its head office is based in Molnlycke, outside Gothenburg. Cochlear Bone Anchored Solutions AB is part of the Cochlear group which is the world leader within hearing implants. The turnover for the total Cochlear group is 3.6 Billion SEK and the organization employs over 1800 people worldwide. Visit www.cochlear.com to learn more about Cochlear and how our products Baha and Vistafix improve the quality of life for people all over the world. Cochlear Bone Anchored Solutions AB can offer you great team environment, opportunities for ongoing learning and career development, international and inspiring company culture, modern office with an innovative climate and free parking. We are looking for a Systems Engineer which role is to make sure that Systems Engineering is properly and efficiently implemented within our technology development projects in such a way that the projects delivers products that meet the user requirements and regulatory standards in an efficient way. Accountabilities and associated responsibilities: This role is the sole systems engineer on a large and complex system, reporting to the System Project Manager but mainly working with engineers from various component projects. Significant initiative and problem solving skills are required to resolve inter disciplinary and inter product design issues. -Manage and co-ordinate Systems Engineering tasks -Management/development of user requirements, system requirements and requirements traceability -Management/development of verification plan -Coordinate and contribute to system design and system integration -Plan and coordinate system verification and validation (tests, protocols & reports) -Project design documentation. -Include Regulatory Requirements into system requirements -Contribute to the preparation of regulatory submissions (CE design dossier, FDA PMA) -Patent disclosures generated from the Systems Engineering work -Practical work (ex. solder, electrical measurements on printed circuit boards) Apart from above you will also work with the Systems Engineering Process improvement in conjunction with other Cochlear Systems Engineers. You make use of and maintain systems engineering tools (requirement handling, issue handling, configuration management etc) and related procedures. Profile: You have a solid understanding of systems engineering principles, methods and tools that is appropriate for the development of implantable medical devices and/ or experience from working in a regulatory controlled enviroment. We also want you to have more than 5 years experience in engineering design and verification. -University degree in science or engineering, preferably Master in Physics or Electrical Eng. -Extensive experience in product development (5-10 years) -Experience in Systems Engineering -Broad view on technology in general As a person you are characterized by initiative, cooperation and problem solving skills. The quality in your work is always in focus and your strategic and analytical skills are excellent. You are a good communicator and a customer oriented team player. Your English reading and writing is fluent.