Sr Engineer, Design Assurance

•    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.

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

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.