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.