o Hands on experience in design and development
o Hands on experience in FDA regulated Design Control, Change Control, NPD flow.
o Good understanding of ISO 13485, 21 CFR Part 820 standards and risk management (ISO 14971)
o Design-related experience and knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties, and regulatory compliance
o Experience in NPD of Plastic/Metal components
o Basic engineering (e.g., statistical techniques, validation protocol, process capability studies, process validation, developing solutions that meet quality, performance, and cost commitments).
o Experience with CAD/CAM and design analysis software with a basic knowledge and understanding of medical regulatory requirements
o Risk Management activities Proven ability to perform root cause investigations, and CAPA process
o Writing technical documents is required
o Expected to lead the engineering change projects with minimal support from client SMEs
o Organizes and conducts Engineering builds