Lediga jobb Scandinavian Real Heart AB i Västerås

To work with existing R&D engineers and control CAD output within the company. To generate innovative designs to solve technical problems and analysis of system performance.
Hands-on testing of designs is expected and the candidate should be comfortable developing testing machinery and performing performance testing of the system.
Responsibilities
To design parts, components, and assemblies of the innovative artificial heart system
To setup CAD output control of company CAD files
Conduct tests at the company facility
To generate reports and documentation in accordance with the company quality system.
Skills and Experience
PhD Degree qualified in mechanical or biomedical engineering focused on development of mechanical circulatory support devices is essential
Bachelor of Engineering in Mechanical Engineering is essential
Work experience in the use of CAD software (Solidworks) is essential
Work experience from total artificial heart research is essential
Experience in a regulated environment such as medical device, defence, automotive or similar would be preferred.
Experience with analysis packages such as Ansys for structural and thermal investigations would be preferred
Experience from reliability testing and in vivo testing of mechanical circulatory support devices would be preferred
Demonstrated ability to work in a small, innovative team.
Proven ability to work with external manufacturing partners and understanding of manufacturing capabilities and processes
Excellent written communications skills, and analytical problem-solving skills. Visa mindre

Scandinavian Real Heart AB (SRH) 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. SRH is based in Västerås, Sweden and listed on Nasdaq First North Growth.
SRH is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a Chief Medical Officer to join the small and dynamic team to oversee all aspects of project management
The ideal candidate will have demonstrated experience in preclinical and clinical project management in the field of medical devices.
Key Objective
To define and implement the preclinical and clinical evaluation plan for the required testing and clinical trials to reach the market in a time efficient and safe manner. To oversee and coordinate different preclinical and clinical research projects in the company to ensure they meet regulatory requirements and commercial goals. Manage the communication with regulatory authorities regarding preclinical data submission and regulatory submission to gain approval to carry out clinical trials. Develop and implement training program for future clinical users. Ethics applications and grant applications for preclinical and clinical studies. Documentation, presentation, and publication of preclinical and clinical data in scientific journals and at conferences.
Responsibilities
To work with the preclinical and clinical teams and corporate management to develop schedules and plans for preclinical and clinical projects
Defining and implementing preclinical and clinical test plans
Manage the data collection, analysis, and presentation of preclinical data
Regulatory submissions to the FDA and communication with notified body
Ethical applications and grant applications
Develop clinical training programs for clinical partners
Build and educate the team and manage and mentor staff
Monitoring projects to ensure goals are met on a daily basis
Budgeting and resource planning

Skills and Experience
Medical doctor or nurse with clinical experience from ICU patients
10 years’ work experience in the field of preclinical artificial heart research
Experience from regulatory submissions to the FDA
Experience from ethics applications and grant applications
Experienced author of scientific publications in peer-review journals
Speaker at scientific conferences
Five years’ experience in a regulated environment such as medical device development.
Demonstrated ability to work in a small, innovative team.
Risk management experience
Cost control and budgeting skills
Proven ability to steer external partners ensuring that project plans are followed, and deviations are communicated.
Excellent verbal and writing communications skills
Fluent in English is a must, Swedish language skills would be valued
Proven networking skills and a good relationship builder Visa mindre

Scandinavian Real Heart AB (SRH) 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. SRH is based in Sweden and is from December 17 publicly traded on Nasdaq First North Growth Market.
SRH is looking for candidates motivated to progress the technology from the research stage to clinical use and commercialization. An opportunity exists for a technician to join the small and dynamic team, reporting directly to the Chief Technical Officer, to support production and assembly of multiples components of the implantable system.
The ideal candidate will have demonstrated experience with electro-mechanical equipment assembly, clean room procedures and have experience in a regulated environment. Such as medical/dental, aerospace, automotive or defence industries.
Key Objective
To assemble parts of the electro-mechanical system ready for pre-clinical evaluation. The role requires someone comfortable in a laboratory, production and clean room setting in a hands-on role to assemble devices with guidance from more senior team members.
Responsibilities
· Assemble medical devices for preclinical evaluation
· Assist in the development of assembly techniques and procedures
· Setup and control production equipment such needed
· Coordinate production activities in the small and dynamic team
Skills and Experience
· Experience as a production technician or similar
· Experience in a regulated environment such as medical device, defence, automotive or similar would be preferred. Dental technicians are invited to apply
· Demonstrated ability to work in a small, innovative team.
· Attention to detail and pride in work output are highly regarded.
To be part of the Real Heart team please submit your application to: [email protected] Visa mindre

Scandinavian Real Heart AB (SRH) 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. SRH is based in Västerås, Sweden and is from december 17 publicly traded on the Nasdaq First North Growth Market.
SRH is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a Program Manager to join the small and dynamic team to oversee all aspects of project management
The ideal candidate will have demonstrated experience in project management in the field of medical devices.
Key Objective
To oversee and coordinates different related projects in the company to ensure they benefit one another and meet business goals. Their main duties include organizing various programs and activities to improve company efficiencies, building long-term goals for company projects and developing program schedules and project budgets.
Responsibilities
To work with various team members and management to develop schedules and plans for projects
Monitoring projects to ensure goals are met on a daily basis
Support management in budgeting and resource planning
To support development of systems and procedures to standardize company activities

Skills and Experience
Degree qualified in an area relevant to the company and ideally MedTech.
Five years work experience as a project manager
Five years’ experience in a regulated environment such as defence, automotive or aerospace and in particular medical device development.
Demonstrated ability to work in a small, innovative team.
Risk management experience
Cost control and budgeting skills
Proven ability to steer external partners ensuring that project plans are followed, and deviations are communicated.
Excellent verbal and writing communications skills
Fluent in English is a must , Swedish language skills would be valued

To be part of the Real Heart team please submit your application to: [email protected] Visa mindre

Scandinavian Real Heart AB (SRH) 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. SRH is based in Västerås, Sweden and is publicly traded on the Swedish stock exchange.
SRH is looking for candidates motivated to progress the technology from the development stage to clinical use and commercialization. An opportunity exists for a senior 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.

Key Objective
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.

Responsibilities
· 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.

Required Skills and Experience
· 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.

Desired Skills and Experience
· Being a good team player.
· Swedish language skills would be valued
· Previous experience from class III medical device development

To be part of the Realheart team please submit your application to: [email protected] Visa mindre

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 responsibilities
· Effectively communicate department or area issues and results within and across functional areas and conducting presentations of details and/or technical information concerning specific projects or timelines
• Lead by example, developing and mentoring R&D team on product development methodology, critical thinking and problem-solving skills and encourage creativity in the R&D team
• Ensure timely and consistent communication to stakeholders (CEO, Management team and Board) on progress, risk management and change management associated with technology and R&D portfolio
· Collaborate with the Founder and Scientific Advisers, in relation to scientific communication, IP strategy,patents, grant applications, clinical trials etc.
· Together with the CEO actively work with key suppliers and lead the strategic purchase development
· Collaborate with and assist the project manager in order to reach the long-term goals.
· Manager for technical team including 5-10 persons both employees and consultants

Managerial
· The R&D Director will be managing a group of engineers both employees and consultants (5-10 persons).
· The members of the team have strong competencies within their own specialities. Some members of the team has participated in the project for a long time, but many of them are relatively new. A key to the success is to make them all work together and to create an environment where everyone is participating to the overall project plan
Education/Experience/Qualification
• Advanced degree in Engineering or Bioengineering required, preferred PhD
• Minimum of 5 years of direct product development and launch experience within medtech
• A minimum of 5 years’ experience of managerial roles
• Deep understanding of Medical technology or very similar technology/system
• Fluent English and Swedish skills in speaking, writing and understanding
The ideal candidate for this role will have experience in new concept and product development. S/he will have a strong working knowledge of design controls, and all relevant regulatory requirements for the design, development and commercialization of medtech products. S/he achieves objectives of technology innovation and product development, after consideration of time, cost and performance standards. S/he applies all relevant international regulations/norms/standards.
Required competencies
In order to be successful, the candidate excels on the following competences:
• Influence
• People management
• Innovation
• Networking
• Effective communication

The following competences are desirable:
• Analysis & judgement
• Steadiness
Mindset & intrapersonal skills
• Excellent organizational, collaborative and leadership skills with demonstrated track record
• Ability to make and prioritize process and resource decisions based on overall team and organizational needs
• Outstanding learning, analytic, problem solving and decision-making skills
• Result focused & Customer -and business orientation
• High level of commitment and personal integrity
• Ability to challenge existing technology, priorities and projects
• Promoting a mutual respect environment humble to each and everyone’s skills and experiences, at company´s
best
• Comfortable in an early stage company with a focus on flexibility, ability to multi-task, attention to detail, good
follow-up and judgment
• Project management and solid process management skills to assure assignments meet timelines, are managed
and known to relevant parties
• Capability to promote teamwork/collaboration, together with an attitude to measure performances by KPIs
• As a person, you should be curious and prestigeless Visa mindre

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. Visa mindre