Mechanical Engineer, Medical Device R&D – Global Impact

X-Therma GmbH; Innsbruck; Hybrid; 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, 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.