Job Description

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 Recent 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: 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

You Unlimited.

We believe

📌 Design Quality Engineer 2 (Pune)
🏢 Smith & Nephew's gynecology business
📍 Pune