Mechanical Design Engineer

Overview

The client is seeking an experienced Mechanical Design Engineer to support the development of next-generation catheter-based medical devices.

The successful contractor will work as part of a multidisciplinary product development team responsible for concept design, prototype development, design verification and design transfer activities. This position offers the opportunity to contribute directly to innovative technologies used in minimally invasive cardiovascular procedures.

Responsibilities

• Design and develop mechanical components and assemblies for medical devices in accordance with ISO 13485
• Produce 3D models and engineering drawings using SolidWorks
• Participate in concept generation and design reviews
• Develop and test prototypes
• Conduct root cause investigations and design improvements
• Support verification and validation activities
• Perform tolerance stack-up analysis and Design for Manufacture (DFM) assessments
• Collaborate with R&D, Quality, Manufacturing and Regulatory teams
• Support risk management activities in accordance with ISO 14971
• Generate design documentation in compliance with FDA and MDR requirements
• Support transfer of products from development into manufacturing

Required Experience

• Bachelor's Degree in Mechanical Engineering or similar discipline
• 5+ years of mechanical design experience
• Experience within Medical Devices, Aerospace, Automotive or another highly regulated industry
• Strong CAD experience (SolidWorks preferred)
• Experience taking products through full development lifecycle
• Understanding of design controls and regulated development processes
• Prototyping and testing experience
• Strong communication skills

Preferred Experience

• Catheter, implantable device or cardiovascular experience
• Nitinol or polymer component experience
• FEA analysis experience
• Design transfer experience
• Medical device documentation experience