Job Summary
Design & Prototyping: Utilize CAD software (e.g., SolidWorks, Creo) to design implants, instruments, or diagnostic systems and build rapid prototypes.
Design Controls: Manage the Design History File (DHF), engineering changes (ECR/ECN), and traceability matrices throughout the product development lifecycle.
Verification & Validation (V&V): Develop test protocols, conduct risk assessments (DFMEA), and perform functional testing to ensure the device is safe and effective.
Regulatory Compliance: Ensure all designs meet global healthcare standards such as FDA 21 CFR Part 820, ISO 13485, and CE mark regulations.
Cross-Functional Collaboration: Partner with Quality Assurance, Regulatory Affairs, Marketing, and manufacturing teams to translate clinical user needs into technical specifications.
Key Responsibilities
2. To design and develop solution for product / project and sustenance delivery.
3. To gather specifications and deliver solutions to the client organization based on understanding of a domain or technology.
4. To guide and mentor a team of developers for successful delivery of project.
5. To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements.