Bachelor’s degree in Engineering, Biomedical, or related field
5+ years of experience in DHF remediation or medical device documentation
Strong understanding of FDA QSR, ISO 13485, and EU MDR requirements
Experience with risk management (ISO 14971), design controls, and product lifecycle documentation
Proficiency in document management systems and quality tools
Excellent attention to detail and organizational skills
Strong communication and collaboration abilities
Engineer • Pune, Maharashtra, India