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

TECCON Consulting GmbH; Österreich; On-site; EUR 47,000 - 57,000; Full time

Benefits offered by this job

Flexi time

Long-term employment

Training & development

Job summary

TECCON Consulting GmbH in Schaftenau, Austria, seeks an expert in medical device testing to independently plan, perform and document mechanical, physical and functional testing. You will develop test methods, manage equipment qualification and contribute to design control documentation.

Join a team of professionals in IT, engineering and business, working across TRD, Operations and other functions to ensure GMP-compliant testing, data evaluation and regulatory readiness.

Qualifications

• Scientific or technical degree with experience in medical devices, lab testing or device development.
• Experience in mechanical, physical or functional testing and validation method development.
• Familiarity with GMP, deviations, OOS investigations and controlled documentation.
• Experience with equipment qualification and maintenance.
• Ability to manage multiple activities and coordinate cross-functional projects.
• Strong analytical and interpretive skills for test data.

Responsibilities

• Plan, perform and document mechanical, physical and functional testing of medical devices and combination products.
• Develop, optimize and support validation and transfer of test methods.
• Manage laboratory equipment, including maintenance and qualification.
• Document, review and interpret test data and plan follow-up experiments.
• Support deviations investigations and corrective actions for out-of-spec results.
• Author and review SOPs, test methods, validation/transfer docs and reports.
• Coordinate testing activities within Device Development projects with TRD, Operations and others.
• Contribute to device characterization and relevant design control documentation.
• Support internal/external audits and regulatory submissions.

Skills

Testing expertise

GMP knowledge

Project management

Analytical skills

Communication

English

Education

Scientific/technical degree

Tools

Laboratory equipment

Job description

Vollzeit | Schaftenau

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.

Your Benefits:

• 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.