Realheart is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a lead systems engineer professional to join the small and dynamic team to lead the development of the clinical version of the electronic system (hardware and software) to meet documented performance requirements.<\/p>\n\n\n\n
A significant portion of this work includes managing communication with and output from international partners.<\/p>\n\n\n\n
The ideal candidate will have demonstrated experience with electronic system development in the field of medical devices.<\/p>\n\n\n\n
To steer the development of the electronic system, consisting of electronics and software, that actuate and control the artificial heart. Ensure that design control guidelines are followed by the local team as well as outsourced works.<\/p>\n\n\n\n
\u00b7 To lead and project manage both in-house and outsourced development of electrical and software components of the system.
\u00b7 To manage system level requirements, test plans and other design control deliverables
\u00b7 Support development of company internal procedures and quality systems and risk management activities.
\u00b7 To generate reports and documentation in accordance with the company quality system and suitable for regulatory submissions.<\/p>\n\n\n\n
\u00b7 Degree qualified in electrical engineering, software engineering or equivalent.
\u00b7 Work experience systems engineering is essential.
\u00b7 Experience in a regulated environment and in particular medical device development.
\u00b7 Excellent verbal and written communication skills in English
\u00b7 Ability to steer external partners to follow project plans and communicate deviations.<\/p>\n\n\n\n
\u00b7 Being a good team player.
\u00b7 Swedish language skills would be valued
\u00b7 Previous experience from class III medical device development<\/p>\n\n\n\n
The role is based at HQ in V\u00e4ster\u00e5s, Sweden.<\/p>\n\n\n\n