Product Development and Engineering Manager

Requisitos

• Bachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field)
• 7+ years of experience in medical device development, design engineering, quality engineering, or technical project management
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR
• Experience with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety & EMC)
• Proven ability to manage cross-functional software and hardware projects, ideally in a sustaining or post-market context