Job Description
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 stable 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 Qualifications




Minimum & Preferred Qualifications and Experience:
- 3+ years of experience in Quality Engineering within the medical device industry, specifically supporting Current 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 Qualificatio

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