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R&D Engineer
2 months ago
Position Overview:
We are seeking a talented R&D Engineer with medical device experience to join our Research and Development team. The role involves supporting the design and development of innovative medical devices, ensuring compliance with industry standards and regulatory requirements. The ideal candidate will have a hands-on approach to product development, process optimization, and prototyping.
Key Responsibilities:
- Product Development: Design, prototype, and develop medical devices, ensuring they meet functional and regulatory requirements.
- Testing & Validation: Conduct tests and validation processes to ensure product performance and safety.
- Regulatory Compliance: Ensure all product development activities comply with regulatory standards such as FDA and ISO 13485.
- Cross-Functional Collaboration: Work closely with cross-functional teams, including Quality, Manufacturing, and Regulatory Affairs.
- Design Improvements: Implement design improvements and optimizations based on feedback and testing results.
- Documentation: Maintain accurate documentation of design processes, test results, and regulatory approvals.
Qualifications:
- Bachelor’s degree in Engineering or a related field.
- 3-5 years of experience in R&D, specifically within the medical device industry.
- Knowledge of FDA regulations and ISO 13485 standards.
- Proficiency in CAD software and experience in prototyping and product testing.
- Strong communication and problem-solving skills.