Engineer – Medical Device Testing & Validation (m/f/d)

TECCON Consulting GmbH; Österreich; Presencial; EUR 47.000 - 57.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working time

Opportunities for specialization

Development opportunities

Pleasant team atmosphere

Work-life balance

Descripción de la vacante

TECCON Consulting GmbH seeks an experienced expert to plan, execute and document mechanical, physical and functional testing of medical devices. You will develop test methods, qualify equipment and interpret data to drive development and regulatory readiness.

Join a dynamic team focused on device development, quality systems and continuous improvement, with opportunities for specialization and long-term growth in a flexible, collaborative environment.

Formación

• Experience with mechanical, physical or functional testing of devices.
• Familiarity with GMP, quality systems and controlled documentation.
• Experience in device development and laboratory testing.

Responsabilidades

• Plan, perform and document mechanical, physical and functional testing of medical devices.
• Develop, optimize and transfer test methods and validate them.
• Manage laboratory equipment maintenance, qualification and records.
• Document and interpret test data to guide next steps in development.
• Support investigations of deviations and OOS results with corrective actions.
• Prepare SOPs, protocols and scientific reports and ensure regulatory readiness.
• Coordinate testing activities across Device Development projects with TRD and Operations.
• Contribute to device characterization and design control documentation.
• Support audits and health authority questions with technical input.
• Identify improvements to testing processes, equipment and lab operations.
• Ensure GMP, quality, safety, environmental and information security compliance.

Conocimientos

Testing expertise

GMP knowledge

Equipment qualification

Project management

Analytical skills

Communication

English proficiency

Educación

Scientific or technical degree

Descripción del empleo

Are you an expert in your field, ready to apply your know-how to exciting projects?

Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.

Your Key Responsibilities:

• Laboratory Testing: You independently plan, perform and document mechanical, physical and functional testing of medical devices and combination products.
• Test Methods: You develop, optimize and support the validation and transfer of test methods.
• Equipment Qualification: You manage specialized laboratory equipment, including maintenance, qualification and related documentation.
• Data Evaluation: You document, review and interpret test data and support the planning of follow-up experiments.
• Deviation & OOS: You support investigations of deviations and out-of-specification results and contribute to appropriate corrective actions.
• Technical Documentation: You author and review SOPs, test methods, validation/transfer documents, protocols and scientific reports.
• Project Collaboration: You coordinate testing activities within Device Development projects and collaborate closely with TRD, Operations and other functions.
• Device Development: You contribute to device characterization and relevant design control documentation.
• Audits & Regulatory: You support internal/external audits and provide technical input for regulatory submissions and health authority questions.
• Continuous Improvement: You identify opportunities to harmonize and improve testing processes, equipment and laboratory activities.
• GMP & Compliance: You ensure compliance with GMP, quality, safety, environmental and information security requirements.

Your Profile:

• Education: You have a scientific or technical degree and relevant experience in medical devices, laboratory testing or device development.
• Testing Expertise: You bring experience in mechanical, physical or functional testing and test method development/validation.
• GMP Knowledge: You are familiar with GMP, quality systems, deviations, OOS investigations and controlled documentation.
• Equipment: You have experience with laboratory equipment qualification and maintenance.
• Project Management: You are able to manage multiple activities, prioritize tasks and coordinate cross-functional projects.
• Analytical Skills: You interpret complex test results and translate findings into practical next steps.
• Communication: You work effectively with interdisciplinary teams, suppliers and external partners.
• English: You have strong written and spoken English skills.
• Exciting, self-organized and responsible tasks
• Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
• Flexi time agreement, flexible working time model, work-life balance
• Opportunities for specialization and subject-specific further education and training
• Extremely collegial team with a friendly approach
• Various development opportunities within the TECCON Group

The gross annual salary is at least EUR 52.000 but of course we offer overpayment in line with the market, depending on qualifications and professional experience.