Mechanical Engineer R&D Medical Devices (m/f/d)

X-Therma GmbH; Innsbruck; On-site; EUR 50,000 - 61,000; Full time

Benefits offered by this job

Home office options

International team

Job summary

X-Therma, an Innsbruck-based startup with a San Francisco origin, seeks a Mechanical Engineer to lead development projects from ideation to production. The role involves steering strategies, coordinating with product, production and QA teams, and ensuring compliance with MDR/ISO 13485 while delivering clear design and manufacturing documentation.

Ideal candidates have several years in medical device development, strong leadership, and fluency in German and English.

Qualifications

• Bachelor-level or higher degree in a relevant field such as medical technology, mechanical engineering, mechatronic engineering, physics, or an equivalent qualification.
• Several years of experience in medical product development and technical project leadership.
• Strong knowledge of medical technology regulations and standards (e.g., MDR, ISO 13485).

Responsibilities

• Provide technical leadership on development projects at different maturity levels.
• Define and steer development strategies and priorities in coordination with management.
• Collaborate with cross-functional teams including product management, production, and quality assurance.
• Analyze technical requirements and implement regulatory standards in medical technology.
• Ensure milestone and budget targets are met.
• Mentor team members and foster a culture of innovation.
• Oversee quality control and risk management in medical product development.
• Contribute to development and optimization of product concepts and prototypes.
• Design and develop new medical devices in line with regulatory requirements (MDR, FDA).
• Create and review technical specifications, design documents, and manufacturing instructions.
• Conduct error analysis and problem-solving to improve product and process quality.
• Monitor production metrics and develop measures to increase efficiency and reduce costs.

Skills

Analytical mindset

Communication skills

Team leadership

Education

Degree in medical technology

Tools

Regulatory standards MDR/ISO 13485

Job description

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 Mechanical Engineer (m/f/d). In this position, you will play a key role in the technical leadership of development projects across various maturity stages – from ideation to prototyping to full-scale production. You will be part of a multidisciplinary and international team, ensuring innovations are implemented effectively and on target.

• Providing technical leadership on development projects at different maturity levels
• Defining and steering development strategies and priorities in coordination with management
• Collaborating closely with cross-functional teams, such as product management, production, and quality assurance
• Analyzing technical requirements and implementing regulatory standards in medical technology
• Ensuring milestone and budget targets are met
• Fostering a culture of innovation within the team and actively mentoring team members
• Overseeing quality control and risk management, especially in the development of medical products
• Contributing to the development and optimization of product concepts and prototypes
• 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.
• 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.
• Report to management on the status of projects and production processes as well as on quality and process improvements.

Your Profile:

• Degree in medical technology, mechanical engineering, mechatronic engineering, physics, or a related field
• Several years of experience in medical product development and technical project leadership
• Solid knowledge of medical technology regulations and standards (e.g., MDR, ISO 13485)
• Proven experience in team leadership and collaboration with cross-functional departments
• Analytical mindset with a strategic approach and a solutions-oriented work ethic
• High degree of initiative, decisiveness, and excellent communication skills
• Fluent in both German and English

What´s in it for You?

• A responsible role in an innovative and dynamic work environment
• Attractive compensation and flexible work models, including home office options
• Opportunities for professional development and career growth
• The chance to contribute to projects that directly impact the health and well-being of people worldwide
• Minimum salary 55.000,00 p.a. depending on qualifications and work experience on a negotiable basis.
• International team with the opportunity to travel frequently.