- We are looking for a Mechanical Engineer with exposure in medical device design and regulatory documentation in compliance with USFDA and EU MDR standards. The ideal candidate will be responsible for developing and maintaining Design History Files (DHF), Device Master Records (DMR), and Technical Files, ensuring compliance with global regulatory requirements.
- Ensure compliance with USFDA and EU MDR regulations, including design input/output documentation, verification, and validation
- Ensure compliance with Good Documentation Practices (GDP) and regulatory requirements.
- Collaborate with cross-functional teams including quality assurance, regulatory affairs, and manufacturing.
- Develop verification and validation protocols and test plans based on product requirements, design specifications, and regulatory standards
- Conduct risk assessments and design reviews to ensure product safety and efficacy.




- Ensure compliance requirements according to ISO 13485, 21 CFR Part 820, CDSCO and EU MDR, ISO 14971 and other applicable regulations and standards.
- Support sustaining engineering, remediation, and recent product development projects.
- Stay updated with new technologies and current industry practices.
- Work on ECO/ECN routing and PLM tools for design modifications.
- Should be able to co-ordinate with marketing team to resolve and product complaints related to design.

Additionally, Design and develop mechanical components for medical devices using CAD software (SolidWorks, Creo, etc.), should be having good 3D CAD knowledge

Short Joiners Preferred :

With Warm Regards,

Jyoti

[email protected]

📌 V & V Engineer (Pune)
🏢 Biorad Medisys
📍 Pune