Design and Development of Medical Devices - Mechanical 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 - Mechanical Engineer

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

Role Overview

As a Design & Development Engineer, you will play a key role in finalizing the mechanical design of our vein harvesting system and ensuring a smooth transition to manufacturing. You will work closely with cross-functional teams, including regulatory, quality assurance, etc., to ensure the design is optimized for production while meeting all safety and regulatory requirements. Your experience in design transfer and manufacturing processes will be critical in ensuring a scalable and compliant product.

Key Responsibilities

• Develop the mechanical design of our vein harvesting system, from proof-of-concept to final design.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to ensure cost-effective and scalable production.
• Collaborate with the engineering team to ensure the design meets functional, regulatory, and manufacturability requirements.
• Oversee the design transfer process to manufacturing.
• Conduct risk analysis and design verification to ensure product safety and compliance with regulatory standards.
• Support the development of mechanical test protocols, verification, and validation activities.
• Coordinate with suppliers and manufacturing partners to ensure all mechanical components meet required specifications.
• Maintain design documentation, including CAD models, drawings, and technical specifications, in accordance with regulatory requirements (ISO 13485).

Qualifications

• Masters degree in Mechanical Engineering or related field.
• At least 3 years of experience in mechanical design and development in the medical device industry.
• Proven experience in design transfer to manufacturing, with knowledge of manufacturing processes and materials.
• Proficiency in CAD software (e.g., SolidWorks or equivalent) for creating models and drawings.
• Strong understanding of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Familiarity with ISO 13485 and other relevant medical device standards is a plus.
• Experience in design validation and testing, including risk analysis (ISO 14971).
• Excellent problem-solving skills and attention to detail.
• Ability to work in a collaborative, cross-functional team environment.
• Strong written and verbal communication skills in English; German proficiency is a plus.

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 mechanical design and want to be part of an innovative medical device start-up in the heart of Vienna, 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 EUR4,000 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