Sr Engineer, Design Assurance

Masimo Corporation; Bengaluru; On-site; INR 700,000 - 900,000; Full time

Job summary

A leading medical device company in Bengaluru is seeking a Quality Engineer with 3+ years of experience to ensure compliance with FDA and ISO standards. The role involves reviewing design requirements, maintaining quality documentation, and managing Design History Files. Ideal candidates will have a Bachelor’s degree in a relevant engineering field, strong analytical skills, and proficiency in quality engineering practices. Competitive compensation and opportunities for international travel are included.

Qualifications

• 3+ years of experience in Quality Engineering within the medical device industry.
• Ability to read and interpret complex engineering drawings.
• Proven experience generating and maintaining DHF documentation.

Responsibilities

• Review and approve design requirements and changes.
• Collaborate to create and maintain risk management files.
• Manage and maintain Design History Files (DHF).
• Perform routine DHF audits for compliance.
• Create and maintain quality documentation.

Skills

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Geometric Dimensioning and Tolerancing (GD&T)

Test Method Validations (TMV)

Problem-solving skills

Communication skills

Leadership/management skills

Proficiency with Microsoft Office

Education

Bachelor’s Degree in Biomedical Engineering

Bachelor’s Degree in Mechanical Engineering

Bachelor’s Degree in Electrical Engineering

Job description

• 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

• 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.