Mechanical Engineer

We are seeking a Senior Mechanical Engineer to design and develop innovative medical device components and systems. This role will be responsible for taking products from concept through manufacturing while ensuring designs meet quality, safety, and regulatory requirements.

The ideal candidate has strong mechanical design experience, advanced CAD skills, and experience developing complex products in a regulated environment.

Responsibilities

• Design and develop mechanical components and assemblies for medical devices.
• Create detailed CAD models, engineering drawings, and product documentation.
• Apply GD&T, tolerance analysis, and design best practices to ensure manufacturability.
• Collaborate with engineering, manufacturing, quality, and suppliers to solve design challenges.
• Support prototype builds, testing, and transition of products into production.
• Perform engineering analysis including structural FEA and basic thermal/fluid analysis.
• Participate in design reviews, risk assessments, and product improvement activities.
• Support compliance with medical device standards and quality requirements.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 5+ years of mechanical design and product development experience.
• Strong experience with CAD modeling (SolidWorks preferred).
• Ability to create detailed engineering drawings and apply GD&T.
• Experience designing complex mechanical assemblies.
• Understanding of manufacturing processes, DFM/DFA principles, and production support.
• Experience with mechanical testing, prototyping, and design verification.

Preferred Qualifications

• Experience working in the medical device industry.
• Knowledge of FDA regulations and ISO 13485 quality systems.
• Experience with FEA/FEM analysis.
• Experience with FMEA, risk analysis, and product safety reviews.
• Experience with injection molding, machining, or other manufacturing processes.
• Knowledge of biocompatible materials and sterilization methods.