Design Quality Engineer 2

Overview

Design Quality Engineer 2 provides quality engineering support for new product development across hardware/software products in the Sports Medicine franchise.

What you'll do

• Develop and plan risk management activities including FMEA, risk controls/mitigation, and verification of effectiveness.
• Provide quality input to user needs, design inputs, software requirements/specifications, and design outputs including CTQ features.
• Conduct design verification, validation, and usability testing, including software/system V&V with protocol/use-case development.
• Develop and maintain engineering design documentation and support design reviews and design history file compilation/audits.
• Support manufacturing quality activities such as MSA, incoming inspection, control plans, process summaries, and process FMEA.
• Prepare regulatory submissions and support audits/inspections.

What you'll need

• 2–5 years of Quality Engineering experience in Medical Device or a comparable regulated industry.
• B.S. in engineering or a technically related field.
• Time management and multi-project planning skills.
• Effective cross-functional collaboration.
• Written and oral communication skills.
• Accountability.

Details

• Location: Kharadi, Pune, India.
• Hybrid work model (stated as for most professional roles).