Systems Engineer (On-site, Denmark)

Job summary

The role involves working as a Systems Engineer within the Research & Development Team, focusing on the verification of products related to advanced bone-anchored hearing systems. The position is based at the Danish site and requires collaboration with various stakeholders across product development.

Qualifications

• Master's degree in engineering (electronics, software, or relevant discipline)
• Minimum of 5 years of verification experience in the medical device industry or a similar regulated industry
• Strong interpersonal skills and a collaborative mindset
• Proficiency in English; knowledge of Danish, French, or Swedish is a plus

Responsibilities

• Execute the R&D verification strategy in development projects
• Analyze product requirements and specifications from a verification perspective
• Participate in product design reviews and team meetings focused on project verification
• Provide guidance on methodologies, tools, and compliance with safety and security standards
• Ensure compliance with quality and regulatory requirements

Skills

• Knowledge of medical device verification standards (ISO 13485, ISO 14971, IEC 62366, IEC 60601)
• Experience with software as a medical device, including CD/CI and cybersecurity aspects
• Familiarity with INCOSE practices; ASEP/CSEP certification is advantageous
• Understanding of hearing implants, hearing aids, or related technologies

Education

• Master's degree in engineering or related field

Tools

• Familiarity with verification methodologies and tools relevant to systems engineering