Austria Job Openings
X-Therma GmbH
Product Engineer Medical Devices (m/f/d)
Innsbruck
August 29, 2024
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!
Tasks
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.
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