Duties & Responsibilities:
• Review and approve design requirements and design changes to ensure appropriate validation and verification (V&V;) requirements are met.
• Collaborate cross-functionally to create and maintain risk management files and documents.
• Ensure all risk assessments are updated concurrently with design changes.
• Manage and maintain Design History Files (DHF).
• Perform routine DHF audits to ensure continuous compliance.
• Create and maintain quality documentation, including quality plans, procedures, and reports.
• Review and approve Test Method Validation (TMV) protocols and reports (e.g., Gage R&R;) to ensure measurement systems are reliable prior to V&V; execution.
• Monitor post-market feedback for early-stage products to ensure reliable field performance, generating summary reports, and field feedback reviews.
• Stay up to date with industry standards and regulations related to medical device quality and implement necessary changes to ensure compliance.
• Perform other duties or special projects as assigned.




Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:

• 3+ years of experience in Quality Engineering within the medical device industry, specifically supporting New Product Development (NPD).
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Strong ability to read and interpret complex engineering drawings, including a solid understanding of Geometric Dimensioning and Tolerancing (GD&T;).
• Proven experience generating and maintaining DHF documentation, risk management documents (DFMEA/UFMEA), and PFMEAs.
• Experience reviewing V&V; protocols and Test Method Validations (TMV / Gage R&R;).
• Experience investigating NCRs and performing root cause analysis.
• Proficiency with Microsoft Office applications.
• Strong communication, documentation, problem solving and leadership/management skills.
• Ability to occasionally travel internationally.
Preferred Qualifications:

• Six Sigma

📌 Sr Engineer, Design Assurance (Bengaluru)
🏢 Masimo
📍 Bengaluru