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.
A significant portion of this work includes managing communication with and output from international partners.
The ideal candidate will have demonstrated experience with electronic system development in the field of medical devices.
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.
· To lead and project manage both in-house and outsourced development of electrical and software components of the system.
· To manage system level requirements, test plans and other design control deliverables
· Support development of company internal procedures and quality systems and risk management activities.
· To generate reports and documentation in accordance with the company quality system and suitable for regulatory submissions.
· Degree qualified in electrical engineering, software engineering or equivalent.
· Work experience systems engineering is essential.
· Experience in a regulated environment and in particular medical device development.
· Excellent verbal and written communication skills in English
· Ability to steer external partners to follow project plans and communicate deviations.
· Being a good team player.
· Swedish language skills would be valued
· Previous experience from class III medical device development
The role is based at HQ in Västerås, Sweden.
To be part of the Realheart team please submit your application to: email@example.com
Ina Laura Perkins
Chief Technology Officer