Medical Device R&D Engineer

• Opportunity to work on a solution with truly significant societal impact

• Chance to translate groundbreaking research into a real-world practical solution

• Position to develop cutting-edge technology in a new frontier of neuroscience

• Supportive environment to grow professionally and personally

• Immersion within an international team that strongly advocates for diversity and inclusion

• Highly competitive salary

• Company laptop and accessories

• Flexible working hours and work from home availability

• Vacation policy

• Additional employee perks

• Design and develop medtech concepts for the treatment of mental health and brain disorders

• Interact with key stakeholders and experts to identify user needs

• Translate technology concepts into prototypes ready for feasibility testing

• Plan, execute and document verification and validation testing of device concepts

• Establish, update and maintain the design history file for new products

• Ensure design control during development in accordance with regulations

• Align with stakeholders and senior management to reach decisions and ensure progress

• Support R&D deliverables and contribute to activities across clinical, product and regulatory fields

• Work independently and self-manage time, completing all tasks with minimal guidance

• Forward Giving: You understand the importance of fostering supportive environments and improving the lives of those around you.

• An Open Communicator: You are proactive, friendly, and can articulate your ideas effectively for collaborating within a multidisciplinary team.

• Organised: You are capable of managing your time and prioritising your work effectively.

• Independent: You are self driven and are at your most effective when given the freedom to define your own priorities and schedule.

• A Trailblazer: At Syntropic we foster and encourage those who strive to make a true positive impact in the world. We believe that innovation is the way to make this change. No technical complexity or difficulty of the problem will prevent our team from seeking life changing solutions.

• Advanced qualification in engineering or a technology discipline (e.g., biomedical, mechanical, electrical/electronic, or similar)

• 2+ years working within medical device research and development for a medical device company or startup.

• Experience with design verification and validation testing of medical device prototypes in accordance with latest regulatory standards

• Technical writing skills and experience with design control processes for medical device development

• Knowledge of medical device regulations and standards (e.g. ISO13485, FDA21CFR part 820, ISO14971)

• Good knowledge of spoken and written English

• Ability to relocate to Vienna, Austria for duration of employment

• EU citizen or existing Austrian red-white-red work permit holder

• Proven experience in product design, development and validation testing for devices with EEG, wearable, neuromodulation, neurostimulation, or neurofeedback applications.

• Successfully taken a medical device product from concept to product launch

• Experience with standards for medical device human factors/usability engineering (IEC 62366)

• Understanding of intellectual property and previous patent filing experience

• Strong understanding of neurotechnology in healthcare and interest in future trends in this space

• Understanding of electrical safety standards for the development of electrical devices (IEC 60601)

• Proficiency with product design and 3D CAD tools such as SolidWorks, CREO, Fusion 360 or similar

• Experience with design transfer processes and good understanding of design for manufacture

• Knowledge of biocompatible materials selection for medical devices

Syntropic Medical GmbH