MedTech Mechanical Engineer

We are looking for a skilled Mechanical Engineer with strong Medical Device industry experience to support the design development and improvement of innovative medical products. The ideal candidate will have hands-on experience in mechanical design product development prototyping and verification/validation activities within a regulated medical device environment.

• 5 years of experience as a Mechanical Engineer in the Medical Device / MedTech industry
• Strong experience designing and developing medical devices surgical instruments diagnostic equipment or electromechanical medical systems
• Experience working through the full medical device product development lifecycle from concept to production
• Hands-on experience with mechanical design 3D modeling assemblies and detailed drawings
• Proficiency with CAD tools such as SolidWorks Creo CATIA or similar
• Strong knowledge of GD&T tolerance stack-up analysis and engineering drawings
• Experience with Design Verification and Validation (DV/V) testing
• Experience with Design Controls Risk Management and documentation for FDA-regulated products
• Knowledge of ISO 13485 quality systems and medical device development processes
• Experience with DFM/DFA injection molding plastics machining and manufacturing processes
• Ability to perform root cause analysis failure analysis and corrective actions
• Experience supporting ECO/ECN processes and product changes

• Design develop and optimize mechanical components and assemblies for medical devices
• Create and maintain engineering drawings specifications and design documentation
• Develop prototypes and support design iterations based on testing results
• Collaborate with cross-functional teams including R&D Quality Regulatory Manufacturing and Suppliers
• Support verification testing validation activities and product releases
• Identify design risks and provide engineering solutions
• Participate in product improvements cost reduction initiatives and sustaining engineering activities
• Ensure designs meet regulatory safety and performance requirements

• Experience with Class II / Class III medical devices
• Experience with FDA submissions DHF (Design History File) DMR documentation
• Experience with biocompatible materials and medical-grade plastics
• Experience with disposable medical devices implants robotics wearables or surgical products

• Bachelors or Masters degree in Mechanical Engineering Biomedical Engineering or related field

Medical Device MedTech Mechanical Design Product Development FDA ISO 13485 Design Controls DV/V SolidWorks Creo GD&T DFM FMEA Prototyping Injection Molding Sustaining Engineering Risk Management.