Sr Engineer, Design Assurance

Masimo Corporation; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading medical devices company in Bengaluru is seeking a Quality Engineer with 3+ years of experience in the industry. The role involves ensuring compliance with FDA and ISO standards, managing design history files, and monitoring product performance. Candidates should hold a relevant Bachelor’s Degree and possess strong communication and documentation skills. The position may require some international travel. Competitive benefits and a supportive work environment are offered.

Qualifications

• 3+ years of experience in Quality Engineering within the medical device industry.
• Strong working knowledge of FDA regulations and ISO standards.
• Proven experience generating and maintaining DHF documentation.

Responsibilities

• Review and approve design requirements to ensure validation requirements are met.
• Create and maintain risk management documents and design history files.
• Monitor post-market feedback for early-stage products to ensure stable performance.

Skills

Quality Engineering

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Geometric Dimensioning and Tolerancing

Root cause analysis

Microsoft Office

Strong communication skills

Education

Bachelor’s Degree in Biomedical Engineering

Bachelor’s Degree in Mechanical Engineering

Bachelor’s Degree in Electrical Engineering

Job description

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 before 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

• 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. The employee must be able to recognize and differentiate color and lift up to 50 pounds. Daily use of computer and other digital devices is required. Standing for extended periods may occur when facilitating meetings, walking in the facilities, performing audits and laboratory testing. Some international travel is required, so a valid international travel passport is necessary. Local travel may also be required; 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 perform them for extended periods. Reasonable accommodation may be made for individuals with real or perceived disabilities.

Location

This position is located at our Bengaluru, India office.

EEO Statement

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