Senior Quality Engineer - Design
Company:
Location:Stockholm, Sweden or Europe
Languages:English
Seniority level:Senior, 5+ years
Experience:5+ years
Skills:
Agile methodologiesComplianceCross-functional collaborationRisk ManagementSoftware EngineeringChange ManagementEnglish communication
Requirements:
5+ years of experience in Design Quality Engineering within the medical device industry Expertise in ISO 13485 Expertise in IEC 62304 Expertise in IEC 62366 Expertise in risk management (ISO 14971) Experience with change management Experience with design transfer to manufacturing Strong understanding of hardware development for medical devices Strong understanding of software development for medical devices Experience with Software as a Medical Device (SaMD) Experience with AI/ML-based technologies Skilled in cross-functional collaboration Skilled in problem-solving Excellent written and verbal communication skills in English
Responsibilities:
Improve and implement design control processes Lead Risk Management for software-driven and AI-enabled technologies Oversee verification and validation strategies for hardware and software Ensure design changes are assessed, documented, and compliant Support technical documentation for regulatory submissions (DHF, Technical Documentation) Facilitate design reviews Drive design transfer to Manufacturing and Operations Ensure process validation and production controls Act as a subject matter expert for audits
