Test & Validation Technician for Medical Devices

vor 10 Stunden

Berlin, Deutschland Novanta Vollzeit

We are seeking a skilled and experienced **Test and Validation Technician** to join our team and help us verify the functional as well as non-functional requirements of our range of pumps and insufflators. As a Test and Validation Technician, you will be responsible for designing, executing, and documenting test and validation activities to ensure that our products meet the required standards and specifications as well as reporting found issues and debug the route cause.

**Key Responsibilities**:

- Develop and maintain test plans, procedures, and protocols for the validation of pumps and insufflators.
- Conduct testing on products, including functional testing, performance testing, and safety testing.
- Use various testing equipment and tools to analyze and interpret test results.
- Collaborate with product design and development teams to ensure that all product designs are fully validated before release.
- Document all test and validation results, including any issues or concerns, and provide recommendations for improvements.
- Conduct regular product and process audits to identify any areas for improvement.
- Stay up to date with industry standards and regulations related to pumps and insufflators and ensure that all testing activities adhere to these standards.
- Investigate any customer complaints or issues related to product quality and provide recommendations for corrective action.
- Work with cross-functional teams to support new product development projects and ensure that testing and validation activities are carried out in a timely and efficient manner.

**Requirements**:

- Technician or Bachelor degree in mechanical engineering or a related field.
- Proven experience in test and validation engineering, with specific experience in medical devices or similar fields is a plus.
- Some knowledge of industry standards and regulations related to pumps and insufflators, including ISO 13485, ISO 14971, and FDA regulations.
- Ability to design and execute complex test plans and protocols and analyze and interpret test results.
- Strong communication skills, with the ability to collaborate effectively with cross-functional teams.
- Excellent attention to detail, and the ability to identify and document issues and concerns accurately.
- Familiarity with testing equipment and tools, such as oscilloscopes, pressure gauges, and flow meters.
- Strong problem-solving skills, with the ability to investigate and troubleshoot issues related to product quality.
- Experience working in a regulated industry, such as medical devices or aerospace, is highly desirable.
- Fluent in English is a must have requirement, German at least on B1/B2 level

Art der Stelle: Vollzeit, Festanstellung

Arbeitszeiten:

- Gleitzeit
- Montag bis Freitag

Leistungen:

- Gleitzeit
- Umzugskostenzuschuss

Arbeitsort: Ein Arbeitsort

Flextime

  • Engineering Technician

    Vor 4 Tagen

    Berlin, Deutschland Novanta Vollzeit

    Active participation in the conceptual design and implementation of a cross-device, uniform test strategy in accordance with the specifications of the architecture group **Main tasks**: - Specification, execution and documentation of system and component verification of devices and accessory products - Development of test specifications (automated and...

  • Lead Regulatory Affairs Specialist Medical Devices

    vor 1 Woche

    Berlin, Berlin, Deutschland Novanta Inc. Vollzeit

    Build a career powered by innovations that matter  At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people's lives and redefining what's possible.  We create for our global customers engineered components and sub-systems that deliver extreme precision and...

  • Lead Regulatory Affairs Specialist Medical Devices

    vor 1 Woche

    Berlin, Berlin, Deutschland Novanta Vollzeit

    Build a career powered by innovations that matter At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and...

  • Regulatory Affairs

    Vor 2 Tagen

    Berlin, Deutschland NonStop Consulting Vollzeit

    Are you a freelance Medical Device Regulatory Affairs Specialist located in Germany or Switzerland? Do you enjoy working on different projects throughout the year? This may be the opportunity for you! My client is seeking Regulatory Affairs professionals for multiple projects running throughout Germany and Switzerland. The projects are running from 1...

  • Lead Regulatory Affairs Specialist Medical Devices

    vor 1 Woche

    Berlin, Deutschland Novanta Vollzeit

    Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and...

  • Systems Engineer Medical Devices

    vor 1 Woche

    Berlin, Deutschland Novanta Europe GmbH Vollzeit

    Please check out the Novanta career site for detailed job description: https://novanta.wd5.myworkdayjobs.com/en-US/Novanta-Careers?q=R008545 This position is part of Novanta’s Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce...

  • Quality Manager

    vor 2 Wochen

    Berlin, Deutschland AURA Health Technologies GmbH Vollzeit

    🏥 About Us At AURA Health Technologies GmbH, we develop AI-powered ultrasound software that makes breast cancer surgery safer, more precise, and more efficient. Our technology brings cutting-edge image processing and artificial intelligence directly into the operating room—with the goal of improving the lives of over 500,000 patients every year. From...

  • Product Manager Medical Devices

    Vor 6 Tagen

    Berlin, Berlin, Deutschland Novanta Inc. Vollzeit

    Build a career powered by innovations that matter  At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people's lives and redefining what's possible.  We create for our global customers engineered components and sub-systems that deliver extreme precision and...

  • Systems Engineer Medical Devices

    vor 2 Wochen

    Berlin, Berlin, Deutschland Novanta Europe GmbH Vollzeit 80.000 € - 120.000 € pro Jahr

    Please check out the Novanta career site for detailed job description:This position is part of Novanta's Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and...

  • Systems Engineer Medical Devices

    vor 2 Wochen

    Berlin, Berlin, Deutschland Novanta Europe GmbH Vollzeit 80.000 € - 120.000 € pro Jahr

    Please check out the Novanta career site for detailed job description:This position is part of Novanta's Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and...