Product Development Engineer
Product Development Engineer
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1 Vacancy
Job Description
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.
Employment Type
Full-time
