Product Development Specialist lll

Overview

Reporting to the Sr. Director Agile Engineering, this member of the product development team is responsible for the product development process from concept to final design review of mechanical components in existing and new AgileMV (a Resonetics company)products. Ensuring the smooth running of all operations activities in line with ISO 13485, FDA, GMPs, CE mark such as the following tasks;

Responsibilities

• Participate in the design and development of medical devices while following a quality system in accordance with ISO 13485.
• Prepare engineering 3D models drawings of products and prototypes.
• Produce and maintain design files in a regulatory framework.
• Participate in risk management and audit.
• Develop and manage design verification and validation activities.
• Manage the transfer of products from design to manufacturing.
• Work with Agile MV customers to identify their needs and p...