Senior Mechanical / Medical Device Design Engineer

About the role

We are seeking a highly experienced Mechanical / Medical Device Design Engineer with 10+ years of experience in medical device design and development. The ideal candidate will have strong expertise in concept development, prototyping, testing, SolidWorks, and manufacturing transfer within a regulated FDA/GMP environment.

Responsibilities

• Lead concept development, mechanical design, prototyping, testing, and product development activities.
• Collaborate with cross-functional teams to design, build, and test next-generation medical devices.
• Apply experimental and analytical methods to evaluate and optimize design solutions.
• Develop and maintain 3D CAD models, engineering drawings, and design specifications using SolidWorks.
• Prepare engineering documentation and communicate technical results to cross-functional teams.
• Design products for manufacturability, including injection molding and other plastic manufacturing processes.
• Support product development from initial concept through manufacturing transfer.
• Perform root cause analysis and resolve complex engineering and design challenges.
• Ensure compliance with company QMS and applicable medical device standards, including ISO 13485 and ISO 14971.
• Work effectively within FDA/GMP-regulated environments.

Requirements

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• 10+ years of medical device design and development experience.
• Strong proficiency in SolidWorks required.
• Proven experience with concept development, prototyping, testing, and product commercialization.
• Strong knowledge of injection molding and plastic manufacturing methods.
• Experience with FDA/GMP-regulated environments.
• Strong understanding of ISO 13485 Quality Systems and ISO 14971 Risk Management.
• Demonstrated experience taking products from concept through manufacturing transfer.
• Strong analytical, problem-solving, root cause analysis, and critical-thinking skills.
• Excellent communication and cross-functional collaboration abilities.
• Ability to develop practical, robust, and manufacturable engineering solutions.

Preferred Qualifications

• Experience designing or developing organ transport systems or related medical transportation technologies.
• Experience with complex electromechanical or life-critical medical devices.
• Strong understanding of Design for Manufacturing (DFM) and Design for Assembly (DFA).