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

TECCON Consulting & Engineering GmbH; Tirol; On-site; EUR 47,000 - 57,000; Full time

Benefits offered by this job

Flexible working time

Career development

Friendly team

Specialization opportunities

Development opportunities within TECCO

Job summary

TECCON Group in Austria is seeking experts to advance testing and development of medical devices. You will independently plan, execute and document mechanical, physical, and functional tests while developing and validating test methods.

You will manage equipment qualification, review data, and support regulatory submissions. The role emphasizes collaboration across TRD, Operations and other functions, with opportunities for specialization, continuous improvement, and a long-term, collegial team

Qualifications

• Scientific or technical degree with relevant experience in medical devices, laboratory testing or device development.
• Experience in mechanical, physical or functional testing and test method development/validation.
• Familiarity with GMP, quality systems, deviations, OOS investigations and controlled documentation.
• Experience with laboratory equipment qualification and maintenance.
• Ability to manage multiple activities, prioritize tasks and coordinate cross-functional projects.
• Analytical skills to interpret complex test results and translate into actionable steps.
• Strong communication with interdisciplinary teams, suppliers and external partners.
• Proficient English, both written and spoken.

Responsibilities

• Plan, perform and document mechanical, physical and functional testing of medical devices.
• Develop, optimize and support validation and transfer of test methods.
• Manage laboratory equipment qualification, maintenance and related documentation.
• Document, review and interpret test data; plan follow-up experiments.
• Support investigations of deviations and OOS results and contribute to corrective actions.
• Author and review SOPs, validation documents and scientific reports.
• Coordinate testing activities within Device Development projects with TRD, Operations and other functions.
• Contribute to device characterization and design control documentation.
• Support audits and provide technical input for regulatory submissions and health authority questions.
• Identify opportunities to harmonize and improve testing processes and lab activities.

Skills

Lab Testing

Test Validation

Equipment Qualification

Data Evaluation

Deviation & OOS

Technical Documentation

Project Coordination

Device Development

Audits & Regulatory

GMP Compliance

English Proficiency

Education

Scientific or technical degree

Tools

Laboratory Equipment

Job description

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.

• 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.

• 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.