Design and Development of Medical Devices - Biomedical Engineer

We are an innovative medical device start-up focused on cardiac surgery, developing a novel vein harvesting system to improve outcomes in coronary artery bypass grafting procedures. Having successfully completed proof-of-concepts, we are now in the critical phase of finalizing our product design, preparing for certification, and transferring the design to manufacturing. Located in the west of Vienna with excellent access to public transport via the U4 line, we offer a dynamic and collaborative work environment where cutting-edge technology and life-saving solutions come together. Join us in shaping the future of cardiac surgery and making a real impact on patients' lives.

Design and Development of Medical Devices - Biomedical Engineer

Full-time position in Vienna (m/f/d)

Role Overview

As a Design & Development Engineer, you will be involved in finalizing the design and development of our vein harvesting system. You will also play a crucial role in preparing detailed technical and scientific documentation, which will be used for regulatory submissions and compliance. This is an ideal position for someone with strong biomedical engineering skills who can also contribute to the scientific writing of clinical and regulatory reports. You will collaborate with the engineering, regulatory, and quality assurance teams to ensure that the product design meets safety and regulatory standards.

Key Responsibilities

• Contribute to the biomedical design and development of the vein harvesting system, ensuring it meets clinical requirements and regulatory standards.
• Prepare, write, and review high-quality scientific and technical documents for regulatory submissions, including design dossiers, clinical evaluation reports (CER), risk assessments, and technical files.
• Conduct thorough literature reviews and produce well-structured scientific reports to support regulatory submissions and internal project documentation.
• Work closely with cross-functional teams, including engineering, clinical, and regulatory departments, to ensure that biomedical design aspects meet both functional and safety standards.
• Support the design verification and validation processes, ensuring that all biomedical design components comply with regulatory requirements.
• Collaborate with quality and regulatory teams to ensure the products compliance with ISO 13485, ISO 14971, and other relevant standards.
• Stay informed about advancements in scientific literature, industry best practices, and evolving regulatory requirements, particularly in the fields of cardiac surgery and medical device development.
• Maintain comprehensive biomedical design documentation in accordance with quality management system and regulatory requirements, with a focus on clarity and accuracy in scientific communication.

Qualifications

• Masters degree in Biomedical Engineering or related field.
• Minimum of 3 years of experience in biomedical design and development, preferably in the medical device industry.
• Proven experience in scientific writing, particularly in preparing technical reports, literature reviews, and regulatory documentation.
• Knowledge of ISO 13485, ISO 14971, and other relevant medical device standards.
• Experience in design verification and validation processes, especially in medical devices.
• Strong research skills, attention to detail, and the ability to produce clear and precise scientific documentation.
• Excellent written and verbal communication skills in English; German proficiency is a plus.
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.

What We Offer

• Competitive salary and benefits package.
• Flexible working hours and flexible remote work options to support work-life balance.
• Professional development opportunities and the chance to grow with the company.
• Convenient office location with excellent public transport connections (U4 line).
• The opportunity to work on life-saving technology in a high-impact role within a fast-growing start-up.
• A dynamic and collaborative environment where innovation and teamwork drive success.
• A supportive team culture with regular team events, fostering a strong sense of community.

How to Apply

If you are passionate about biomedical engineering and scientific writing and want to play a key role in a cutting-edge medical device project, we would love to hear from you! Please send your CV and a cover letter via smart apply.

We have set a minimum gross salary of EUR3.500 per month for this position. However, we are open to offering higher compensation based on your qualifications and experience.

Valeriot FlexCo
Dipl.-Ing. Dipl.-Ing. Michael Flatscher
office@valeriot.com
Elßlergasse 26/8
1130 Wien
Web: http://www.valeriot.com