Medical Device Testing & Validation Engineer - Flexible Hours

teccon-consulting; Tirol; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working time

Career development

Friendly team

Specialization opportunities

Development opportunities within TECCO

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Lab Testing

Test Validation

Equipment Qualification

Data Evaluation

Deviation & OOS

Technical Documentation

Project Coordination

Device Development

Audits & Regulatory

GMP Compliance

English Proficiency

Formazione

Scientific or technical degree

Strumenti

Laboratory Equipment

Descrizione del lavoro

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