Product Development Engineer

Product Development Engineer – Orthopedic Medical Devices

Boston, MA | Hybrid

We are seeking an orthopedic Product Development Engineer with to support next-generation orthopedic surgical technologies focused on Hip, Knee, and shoulder applications. This role will support new product development, sustaining engineering, and continuous improvement initiatives involving advanced robotic-assisted and technology-enabled surgical systems.

Responsibilities

• Develop and maintain engineering documentation, CAD models, and manufacturing drawings
• Support product design, verification, validation, and testing activities
• Perform tolerance stack analysis, structural assessments, and design evaluations
• Support sustaining engineering and continuous improvement projects
• Partner cross-functionally with Quality, Regulatory, Manufacturing, Clinical, and R&D teams
• Support DHF, CAPA, and risk management documentation
• Ensure compliance with FDA, GMP, and quality system requirements

Qualifications

• Degree in Mechanical Engineering, Biomedical Engineering, or related field
• 2+ years of engineering experience within medical devices or another regulated industry
• CAD experience with SolidWorks and/or Siemens NX
• Knowledge of product development, manufacturing processes, and design controls
• Strong communication and problem-solving skills

Preferred Experience

• Orthopedic medical device experience
• Robotics-assisted or enabling technology experience
• Exposure to DHF, CAPA, and regulated product development environments