Product Development Engineer

Job Description:
Our client, a leading medical device manufacturer, is seeking a Product Development Engineer to join their dynamic R&D team. This individual will play a critical role in the design, development, and validation of innovative medical devices that improve patient outcomes. The engineer will collaborate cross-functionally to translate user needs into design requirements, support prototype development, and ensure products meet all regulatory and quality standards.
Responsibilities:

• Participate in the design and development of new medical devices, components, and systems from concept through commercialization.
• Translate user needs and clinical requirements into robust engineering specifications and product designs.
• Develop, evaluate, and refine design concepts, CAD models, and technical drawings using tools such as Creo, SolidWorks, or equivalent.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Clinical Affairs.
• Conduct design verification and validation testing, ensuring compliance with FDA, ISO 13485, and other applicable regulations.
• Support risk management activities including FMEA, hazard analysis, and mitigation strategies.
• Document all design and development activities per Design Control requirements (21 CFR Part 820).
• Provide technical input for design reviews, product specifications, and project plans.
• Partner with suppliers and manufacturing teams to ensure design for manufacturability and scalability.
• Investigate and resolve technical issues during prototype and production phases.

Requirements:

• Bachelor's degree in mechanical engineering, Biomedical Engineering, Product Development Engineering, or related field.
• 3-7 years of experience in product development within the medical device industry.
• Strong knowledge of medical device design controls, risk management, and regulatory requirements (FDA, ISO 13485, ISO 14971).
• Proficiency in CAD tools (Creo, SolidWorks, or similar).
• Experience with prototype development, design verification, and validation testing.
• Hands-on experience with materials selection, tolerance analysis, and root cause problem solving.
• Strong communication skills and ability to collaborate in cross-functional, regulated environments.
• Preferred: Experience in Class II/III medical devices, disposable devices, or electromechanical systems.