Product Development Engineer II

The role involves supporting assigned customers to ensure the best design and quality for medical products, maintaining communication between the company and customers.

• Design and develop class III implantable devices
• Manage product development projects
• Interact with customers professionally and proactively
• Maintain Design History Files and prepare documentation release packages
• Identify trends and process gaps for corrective actions and improvements
• Lead the training of staff and oversee process validation documentation

• Bachelor’s degree in engineering
• 3+ years of medical device product design experience
• Familiarity with FDA, QSR, and ISO 13485 regulations
• Ability to bring products from concept to market
• Strong communication and organizational skills
• Knowledge in clinical, product, and technical areas
• Flexibility, persistence, and an entrepreneurial spirit