Senior Mechanical Engineer

We are seeking an experienced Senior Mechanical Engineer to join an innovative medical device organization specializing in diagnostic technologies. This hands-on role offers the opportunity to work across the full product lifecycle, from concept and design through testing, manufacturing, and commercialization. The ideal candidate is a creative problem solver with strong mechanical design expertise and experience developing complex medical devices.

Requirements of the Senior Mechanical Engineer:

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• 8–15 years of relevant mechanical engineering experience, preferably within the medical device industry.
• Proficiency in SolidWorks CAD software, including mechanical component and assembly design.
• Experience working with biocompatible materials, adhesives, and material processing techniques.
• Strong background in engineering mechanics, electromechanical design, and manufacturing processes.
• Experience designing production fixtures and supporting manufacturing process improvements.
• Excellent analytical, troubleshooting, technical documentation, and cross-functional communication skills.
• Knowledge of FDA, ISO, CE Mark, and EU MDR requirements preferred; experience with circuit design, flexible circuits, or miniature components is a plus.

Responsibilities of the Senior Mechanical Engineer:

• Design, develop, and document mechanical components and systems for advanced medical diagnostic devices.
• Provide engineering support for existing products, troubleshooting complex manufacturing and production challenges.
• Develop and optimize product designs, manufacturing processes, and production fixtures to improve performance, reliability, and manufacturability.
• Create and execute test plans to evaluate product functionality, performance, and compliance with specifications.
• Research and evaluate new materials, technologies, and manufacturing processes to enhance product quality and reduce costs.
• Lead failure investigations, identify root causes, and implement corrective actions to improve product reliability.
• Support product verification, validation, and regulatory compliance activities in accordance with FDA, ISO, and EU MDR requirements.
• Collaborate with cross-functional teams and external suppliers to resolve technical challenges, maintain engineering documentation, and support product commercialization.