We are seeking a highly skilled and motivated R&D Engineer to join our team. The successful candidate will play a crucial role in the verification and validation of medical devices, including FDA 510k projects, ISO 13485 compliance, and FDA 21CFR Part 820 adherence. The responsibilities will also encompass the verification and validation of infusion pump products.
Qualifications:
- Bachelor’s or master’s degree in biomedical engineering, Mechanical Engineering, or a related field.
- Minimum of 3-5 years of experience in the medical device industry, with a focus on R&D, verification, and validation.
- In-depth knowledge of FDA 510k submission process and requirements.
- Strong understanding of ISO 13485 and FDA 21CFR Part 820 regulations.
- Firsthand experience with verification and validation processes for medical devices.
- Experience with cleaning and disinfecting products for medical devices is highly desirable.
- Strong analytical and critical thinking skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team environment.
- Meticulousness and strong organizational skills.
- Proficiency in relevant software tools and technologies.