Design Quality Engineer 2

smithnephew; India; On-site; INR 900,000 - 1,600,000; Full time

Benefits offered by this job

Major medical coverage

Educational Assistance

Hybrid Work Model

Parental Leave

Employee Assistance Program

Job summary

Smith+Nephew seeks a Design Quality Engineer to support New Product Development for hardware/software in the Sports Medicine franchise. You will work with cross-functional teams to plan activities and ensure design control and risk management compliance.

You will contribute to risk management, design verification/validation, and regulatory readiness while developing and releasing engineering design documentation. Hybrid work model offered.

Qualifications

• Experience with ISO 14971 risk management.
• Knowledge of IEC 62304 software life cycle.
• Familiarity with ISO 13485 quality system.
• Strong time management and multi‑project planning.
• Proven cross-functional collaboration.
• Excellent written and verbal communication.
• 2–5 years in quality engineering in medical devices.

Responsibilities

• Develop risk management files including planning and FMEA.
• Provide quality input to user needs, design inputs/outputs.
• Design verification, validation and usability testing; V&V protocols.
• Develop engineering design documents; support design reviews and DHF.
• Manufacturing quality activities: MSA, incoming inspection, control plans.
• Regulatory submission preparation and audit support.

Skills

Risk Management

ISO 14971

IEC 62304

ISO 13485

Time management

Multi-project planning

Cross-functional collab

Communication skills

Accountability

Quality Engineering (2-5 yrs)

Job description

Life Unlimited. At Smith+Neu 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%)

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

Y ou Unlimited.

We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve.

Other reasons why you will love it here!

• Major medical coverage + policy exclusions and insurance non-medical limit.
• Educational Assistance.
• Work/Life Balance : Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave.
• Flexibility : Hybrid Work Model (For most professional roles)
• Your Wellbeing: Parents/Parents-in-Law's Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave.
• Training: Hands-On, Team-Customized, Mentorship.
• Stay connected by joining our Talent Community .
• We're more than just a company - we're a community!

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer.

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving.

Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/ ).