Design Quality Engineer 2

Smith & Nephew Gbs; Pune District; On-site; INR 1,000,000 - 1,600,000; Full time

Job summary

Smith+ Nephew is seeking a Design Quality Engineer to provide quality engineering support for New Product Development of hardware/software in the Sports Medicine franchise. The role collaborates with project teams to manage plans and ensure design control and risk management activities align with internal procedures and standards.

Responsibilities include risk management file development, quality input to design outputs, V&V activities, and regulatory submission support, with a focus on

Qualifications

• Risk Management per ISO 14971 (preferred)
• Medical device software development per IEC 62304 (preferred)
• ISO 13485 (preferred)
• Time management and multi-project planning
• Effective cross-functional collaboration
• Written and verbal communication
• Accountability
• 2–5 years Quality Engineering in medical device or regulated industry

Responsibilities

• Develop risk management files including planning, FMEA, mitigation and verification of effectiveness (15%)
• Provide quality input to NPD: user needs, design inputs, software requirements and CTQ features (25%)
• Oversee design verification, validation and usability testing; software/system V&V including protocol and test reporting (25%)
• Develop and release engineering design documentation; support design reviews and DHF compilation/audit (10%)
• Engage in manufacturing quality activities: MSA, incoming inspection, control plans and FMEA (5%)
• Support regulatory submission and audit/inspection activities (10%)

Skills

Risk management

Multi-project planning

Cross-functional collaboration

Written/oral communication

Accountability

Quality engineering

Time management

ISO 14971

Education

B.S. in engineering

Job description

Job Summary

Life Unlimited. At Smith+ Nephew, we design and manufacture technology that takes the limits off living as the Design Quality Engineer you would be Reporting into the Quality Department, this role provides Quality Engineering support for Smith & Nephew New Product Development activities for Hardware/Software products in the Sports Medicine franchise. Works collaboratively with project team members to develop and manage project plans and activities related to new product development. Responsible for supporting the execution of design control and risk management activities in accordance with internal procedures and applicable standards/regulations.

What will you be doing

• Risk management file development: Risk management planning, use/design/software FMEA, risk control and mitigation, verification of effectiveness (15%)
• Cross-functional NPD support: Quality input to user needs, design inputs, software requirements, specifications and design outputs including CTQ features (25%)
• Design verification, validation and usability testing; software/system V&V including protocol/use case development, test execution and report writing (25%)
• Development and release of engineering design documentation; support design reviews and design history file compilation/audit activities (10%)
• Manufacturing quality activities including MSA, incoming inspection, control plans, process summaries and process FMEA (5%)
• Regulatory submission preparation and audit/inspection support (10%)

Education

Education: B.S. in engineering or technically related field

What will you need to be successful

• Risk Management per ISO 14971 (preferred)
• Medical device software development per IEC 62304 (preferred)
• ISO 13485 (preferred)
• Time management, multi-project planning
• Effective cross-functional collaboration
• Written/oral communication skills
• Accountability
• 2-5 years Quality Engineering experience in Medical Device or comparable regulated industry