Senior Quality Engineer - New Product Development (Medical Devices)

About the Role

Join Meril as a Senior Quality Engineer focused on New Product Development (NPD) within the medical devices sector. In this critical role, you will contribute to ensuring the delivery of safe, effective, and compliant devices by leading quality efforts from product concept through commercialization.

You will work cross-functionally with teams including Design Engineering, Test Engineering, Advanced Operations, Manufacturing, Regulatory Affairs, and Supplier Quality to uphold quality standards throughout the product lifecycle.

Responsibilities

• Lead and oversee Design Assurance tasks for new medical device development.
• Ensure compliance with FDA regulations, ISO 13485, and other relevant standards.
• Create and manage Design History Files (DHF) and Risk Management Files to maintain traceability and compliance.
• Facilitate various failure mode analyses such as design (dFMEA), process (pFMEA), usability (uFMEA), along with hazard and functional analyses.
• Support verification, validation, process, software, and sterilization validation activities to confirm product quality and compliance.
• Collaborate with Manufacturing and Advanced Operations teams during design transfer phases.
• Contribute to supplier qualification processes including PPAP submissions, supplier validation, and ongoing quality improvement initiatives.

Requirements

• Bachelor's degree in Biomedical, Mechanical, Electrical, Manufacturing Engineering, or related engineering discipline.
• Between 5 and 10 years of experience in Quality Engineering, Design Assurance, or Product Development within the medical device industry.
• Strong familiarity with Design Controls, Risk Management per ISO 14971, and regulated product development processes.
• Prior involvement supporting New Product Development projects.
• Excellent analytical ability combined with strong communication and cross-functional collaboration skills.
• Proven capability to manage multiple priorities and independently deliver quality-driven results.

Personal Attributes

• Proactive and self-motivated professional taking full ownership of responsibilities.
• Effective collaborator who builds and maintains productive stakeholder relationships.
• Data-informed problem solver dedicated to continuous quality improvement.

Additional Information

This position is based in Gurugram, Haryana, India, and requires onsite engagement. The role does not provide stipend or salary details publicly. If you seek to drive impactful innovations in medical device quality, we welcome your application or profile submission.