About this role
R&D Engineering Manager at Molded Devices (Aptyx). Location: Charlotte, North Carolina, United States. Role: leading teams, developing products, ensuring compliance Requirements: Bachelor's in engineering required; 5+ years medical device product development experience, 2+ years engineering leadership; experience with Class II/III devices, catheter-based products, FDA Design Controls, ISO 13485/14971, V&V, DFMEA/PFMEA, GD&T, CAPA, and design transfer. Category: Engineering Seniority: Senior Level Tools: Design Controls, Design History Files (DHF), FMEA, DFMEA, PFMEA, GD&T, Verification & Validation, Risk Management (ISO 14971), CAPA, Statistical Analysis, Lean Manufacturing Commitment: Full Time Workplace: Onsite Languages: English