Sr Engineer, Design Assurance

Skip to main content.

View More Jobs

Sr Engineer, Design Assurance

Bengaluru, India

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 & 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 Green Belt Certification;

• • Certified Quality Engineer (CQE);

Education

Bachelor’s Degree (B.E.) in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.

Language requirements

• Advanced English proficiency (written and verbal) required to collaborate effectively with cross-functional team members and prepare documentation.

Physical requirements/Work Environment

This position works in office, laboratory, and manufacturing environments. It requires frequent sitting, standing and walking. He or she needs to be able to recognize and differentiate color. He or she must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, performing audits and laboratory testing. Some international travel is required, so a valid international travel passport is required. Also, some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid driver license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

This position is located at our Bengaluru, India office.

Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level.

Apply Now

Job Info

• Job Identification3693
• Job CategoryASIC Design Engineering
• Posting Date05/07/2026, 05:38 AM
• Job ScheduleFull time
• LocationsIN-Bangalore

Similar Jobs

• Engineer, Computer Software Assurance\ \ Bengaluru, IndiaPosted on 07/01/2026\ \ Trending\ \ The Principal Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in GxP processes at Masimo comply with global regulatory requirements. This role provides strategic oversight of CSV activities across the organization, ensuring compliance with FDA, ISO, and global regulations while enabling efficient and robust system implementations. The Principal CSV Engineer serves as the subject matter expert for validation best practices, data integrity, and software lifecycle processes, partnering with cross functional teams to maintain a compliant computerized environment.

American English

• العربية

• Deutsch

• American English

• Español

• Français

• Italiano

• 日本語

• 한국어

• Nederlands

• Polski

• Русский

• Svenska

• Türkçe

• 简体中文

• 繁體中文

• Careers

• Experienced

• Home

I am an employee

This site uses cookies and related technologies for site operation, analytics, and third party advertising purposes. You may choose to consent to our use of these technologies, reject non-essential technologies, or further manage your preferences.Learn more

AcceptDecline

Are You Still With Us?

It seems you've been gone for a while. For security reasons we will end your session automatically in 03:00 unless you would like to continue working.

End SessionContinue Working

Work Summary

This summary is generated by AI Assist. Click inside the summary text box to make changes as necessary.

DiscardAdd Summary

Page Sr Engineer, Design Assurance - Masimo Careers loaded