Mechanical Design Lead

Scandinavian Real Heart AB (Realheart) is developing a Total Artificial Heart (TAH) called the ‘Realheart TAH’ that replaces the natural heart and is intended to save the lives of patients suffering late stage heart failure. Realheart is based in Västerås, Sweden and is publicly traded Spotlight Stock Market
Realheart is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a senior design engineer professional to join the small and dynamic team to support design activities to meet documented performance requirements.
The ideal candidate will have demonstrated experience with electro-mechanical equipment development in the field of medical devices.

Key Objective
To lead the mechanical design and development activities and generate innovative designs to solve technical problems. To document designs and control design output specifications.
Some level of hands-on testing of designs and prototype assembly is expected, and the candidate should be comfortable at both CAD design tasks and in laboratory/workshop environments.


Responsibilities
1. To design parts, components, and assemblies of the innovative artificial heart system.
2. To control and be responsible for all company CAD output and files.
3. Conduct tests at the company facility and build device prototypes.
4. To generate reports and documentation in accordance with the company quality system and suitable for regulatory submissions.

Skills and Experience
1. Degree qualified in mechanical or biomedical engineering or equivalent.
2. Five years industrial work experience in the use of Solidworks is essential.
3. Five to ten years’ experience in a regulated environment and in particular medical device development.
4. Demonstrated ability to work in a small, innovative team.
5. Proven ability to work with external manufacturing partners and understanding of manufacturing capabilities and processes.
6. Excellent written communications skills, English communication skills, and analytical problem-solving skills.