Senior Systems & Usability Engineer — MedTech for Critical Care

MEQU Warmer Systems Corp.; København; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

MEQU is growing its R&D team and seeks a Senior Systems & Usability Engineer to connect user needs, system requirements, risk management and verification across the °M Warmer System.

Based in Copenhagen, you will influence regulatory documentation, design reviews and usability activities, working with cross-functional teams to ensure safe, intuitive medical devices used worldwide. CE/FDA experience is advantageous.

Qualifications

• Bachelor's or master's in engineering or related technical field.
• Several years of engineering experience in systems or usability engineering for medical devices.
• Experience with requirements engineering and traceability.
• Knowledge of design control, risk management and medical-device product development.
• Knowledge of IEC 62366 and ISO 14971.
• Strong analytical, technical and documentation capabilities.
• Strong communication across technical disciplines.
• User-focused, quality-driven product development mindset.
• Experience with FDA-regulated devices, CE marking/MDR, usability validation or human factors engineering is a bonus.

Responsibilities

• Define, structure and manage system requirements and support decomposition.
• Translate user needs into clear, testable product and system requirements.
• Maintain end-to-end traceability between user needs, requirements, risks, design outputs and verification evidence.
• Support system architecture, interface definition and technical decision-making.
• Plan, lead and document usability-engineering activities per IEC 62366.
• Plan and conduct formative usability evaluations and support summative validation.
• Contribute to use-related risk analysis and align usability with ISO 14971.
• Prepare and maintain usability-engineering documentation and other design-control deliverables.
• Support design reviews, changes, verification activities and regulatory submissions.
• Collaborate across R&D, Quality, Regulatory Affairs and external stakeholders; help evolve processes.

Skills

Systems engineering

Usability engineering

Medical-device development

Regulatory knowledge

Documentation skills

Education

Bachelor's or Master's degree in engineering

Job description

MEQU is growing its R&D team and seeks a Senior Systems & Usability Engineer to connect user needs, system requirements, risk management and verification across the °M Warmer System.

Based in Copenhagen, you will influence regulatory documentation, design reviews and usability activities, working with cross-functional teams to ensure safe, intuitive medical devices used worldwide. CE/FDA experience is advantageous.