Product Development Engineer

Product Development Engineer – Orthopedic Medical DevicesBoston, MA | HybridWe 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.ResponsibilitiesDevelop and maintain engineering documentation, CAD models, and manufacturing drawingsSupport product design, verification, validation, and testing activitiesPerform tolerance stack analysis, structural assessments, and design evaluationsSupport sustaining engineering and continuous improvement projectsPartner cross-functionally with Quality, Regulatory, Manufacturing, Clinical, and R&D teamsSupport DHF, CAPA, and risk management documentationEnsure compliance with FDA, GMP, and quality system requirementsQualificationsDegree in Mechanical Engineering, Biomedical Engineering, or related field2+ years of engineering experience within medical devices or another regulated industryCAD experience with SolidWorks and/or Siemens NXKnowledge of product development, manufacturing processes, and design controlsStrong communication and problem-solving skillsPreferred ExperienceOrthopedic medical device experienceRobotics-assisted or enabling technology experienceExposure to DHF, CAPA, and regulated product development environments