Product Engineer Medical Devices (m/f/d)

X-Therma is a fast-moving and innovative startup from San Francisco with an office and hardware R&D branch in Innsbruck, Austria. We are developing breakthrough technology to improve modern medicine and save billions of lives. With our subzero storage and transport solutions, we are enabling global access to organ transplants as well as cell and gene therapy products and engineered tissues.

To strengthen our growing team in Innsbruck, we are looking for a Product Engineer (m/f/d). You will support the process of research and development and take care for our products that are in serial development and will be commercialized soon!

Your Tasks

• Design and development of new medical devices in accordance with regulatory requirements (e.g., MDR, FDA).
• Create and review technical specifications, design documents, and manufacturing instructions.
• Collaborate closely with internal departments such as Research & Development, Quality Assurance,
• and Regulatory Affairs to drive product development.
• Plan, organize, and oversee production processes for medical devices to ensure they are efficient, timely, and meet quality standards.
• Support the implementation and optimization of production procedures, methods, and technologies.
• Ensure compliance with GMP guidelines and other regulatory requirements in production.
• Conduct error analysis and problem-solving to continuously improve product and process quality.
• Monitor production metrics and develop measures to increase efficiency and reduce costs.
• Participate in internal and external audits as well as in the preparation and execution of validations and verifications.
• Create and maintain technical documentation, including production records, test reports, and validation documents.
• Report to management on the status of projects and production processes as well as on quality and process improvements.

Your Profile

• Degree in medical engineering, mechanical engineering, production engineering, or a comparable qualification.
• Several years of professional experience in the development and production of medical devices or a similar function.
• In-depth knowledge of relevant regulatory requirements and standards (e.g., ISO 13485, MDR, FDA).
• Experience in applying quality management methods and tools (e.g., Six Sigma, Lean Manufacturing).
• Strong problem-solving skills and analytical thinking.
• High level of initiative, responsibility, and teamwork skills.
• Excellent command of German and English, both written and spoken.

What‘s in it for you

• 38,5 hrs per week, flexible working hours.
• Minimum salary 50.000,00 p.a. depending on qualifications and work experience on a negotiable basis.
• Home office and on-site workplace.
• International team with the opportunity to travel frequently.
• An exciting and varied work environment in an innovative company.
• The opportunity to actively contribute to the development and production of highly innovative medical devices.
• An open and collegial work atmosphere with flat hierarchies.

Send your application with resume!