Sr Engineer, Design Assurance

Masimo Corporation; United States; On-site; USD 10,350 - 18,630; Full time

Job summary

Masimo Bengaluru offices seek a Quality Engineer to review design requirements, approve V&V plans, and maintain comprehensive DHF documentation. You will collaborate across functions to update risk assessments (DFMEA/UFMEA) and PFMEAs, ensuring compliance with FDA/ISO standards.

You will audit DHF and TMV/Gage R&R reports, monitor post-market feedback, and drive field performance reviews. International travel may be required, with a proactive approach to risk and quality improvements.

Qualifications

• Strong communication, documentation, problem solving and leadership/management skills.
• Experience generating and maintaining DHF documentation, risk management documents (DFMEA/UFMEA), PFMEAs.
• Ability to review V&V protocols and TMV/Gage R&R reports.

Responsibilities

• Review and approve design requirements and design changes to ensure V&V requirements are met.
• Collaborate to create and maintain risk management files and documents.
• Maintain DHF and perform routine audits for compliance.
• Review TMV protocols and Gage R&R to ensure measurement reliability.
• Monitor post-market feedback and generate summary reports.

Skills

Leadership

Documentation

Problem solving

Communication

Education

Bachelor's Degree in Biomedical Engineering

Tools

Microsoft Office

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:

• 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.