Quality team member, allocated to R&D project as Design Assurance Engineer in the field of innovative cardiovascular products.
• Perform quality activities per ISO 13485/FDA 21 CFR part 820 related to design control (e.g., design requirements, risk management, design verification and validation, design reviews)
• Generate and/or review documents such as: design documents, drawings, work instructions, root cause analysis

Required Education/Skills:
• High technical skills, hands-on
• Great interpersonal relationship
• Proficient in English and technical writing
• Organized and meticulous, detailed-oriented
• Strong problem-solving and critical thinking skills
• Independence and prioritizing abilities

Required Experience & Education:
• B.Sc. in Mechanical/Electrical/Biomedical Engineering, or equivalent
• 3-10 years of experience in medical device field or equivalent
• Quality Management System experience in medical devices

Advantage experience:
• Cardiovascular medical device… experience
• Knowledge in statistical techniques
• Project management experience in medical devices
• Former employee of a large international company / Interactions with business units in US