Medical Device R&D Engineer: Design & Validation

Lina Medical; Poznań; Hybrid; PLN 60,000 - 90,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible working hours

English lessons

Job summary

Lina Medical in Poznań is seeking a hands-on R&D Engineer to contribute to testing, documentation and product management of new medical devices. You will engage in end-user evaluation and help identify new regulatory activities.

You will lead usability and design validation, assist with root-cause analysis, and prepare technical documentation in line with ISO 13485, MDR and IEC 60601. A team-oriented, hands-on mindset is essential.

Qualifications

• Experience in similar role (min 2 years) in Medical Device Industry is preferred.
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993 is advantageous.
• Hands-on willingness to work with devices and perform testing.

Responsibilities

• Participate actively in R&D projects for new medical devices focusing on testing and documentation.
• Contribute to Product Management through end-user evaluation and identifying new activities.
• Lead usability and design validation efforts.
• Support root cause analysis and assist with complaints when required by R&D engineering.
• Ensure work aligns with QMS and international standards for Medical Devices.

Skills

Team collaboration

Prioritization

Regulatory standards awareness

Tools

Metrological equipment

Laboratory equipment

Job description

Lina Medical in Poznań is seeking a hands-on R&D Engineer to contribute to testing, documentation and product management of new medical devices. You will engage in end-user evaluation and help identify new regulatory activities.

You will lead usability and design validation, assist with root-cause analysis, and prepare technical documentation in line with ISO 13485, MDR and IEC 60601. A team-oriented, hands-on mindset is essential.