Sr Engineer, Design Assurance

Masimo Corporation; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

A leading medical device company located in Bengaluru is seeking a Quality Engineer to ensure compliance with design requirements and regulations. The role involves managing Design History Files, performing audits, and reviewing validation protocols. Candidates should have a Bachelor's degree and at least 3 years of experience in Quality Engineering within the medical device sector. This position requires a strong knowledge of FDA regulations and ISO standards, along with solid leadership and problem-solving skills. Occasional international travel may be required.

Qualifications

• 3+ years of experience in Quality Engineering within medical devices.
• Strong knowledge of FDA 21 CFR Part 820 and ISO standards.
• Ability to interpret complex engineering drawings.

Responsibilities

• Review and approve design requirements.
• Collaborate to maintain risk management documents.
• Perform routine audits on Design History Files.

Skills

Quality Engineering

FDA regulations knowledge

Geometric Dimensioning and Tolerancing (GD&T)

Problem-solving

Leadership/management skills

Communication skills

Microsoft Office proficiency

PFMEAs

V&V protocols review

Gage R&R

Root cause analysis

Microsoft Office

Leadership

Travel internationally

Education

Bachelor’s Degree in Biomedical 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.