Product Development - R&D Engineer

Overview

Seeking a Product Development / R&D Engineer with hands-on experience or strong exposure to stent development within the medical device industry. The role will focus on design, development, testing, and regulatory documentation to support new product introduction and lifecycle management.

• 5+ years of product development or R&D experience in medical devices
• Hands-on experience or exposure to stent design and development (vascular/peripheral/coronary)
• Experience with design controls and DHF documentation
• Knowledge of FDA 21 CFR Part 820 and ISO 13485
• Experience in design verification & validation (DV&V), testing protocols, and root cause analysis
• Proficiency in CAD tools (Solid Works or similar)

• Support stent product design and development activities from concept to commercialization
• Prepare and maintain design documentation (DHF, risk management, protocols, reports)
• Execute design verification and validation testing
• Collaborate with manufacturing, quality, and regulatory teams
• Participate in design reviews, risk assessments (FMEA), and change management
• Support continuous improvement and product lifecycle activities