Design Quality Engineer 1

Smith+Nephew; Pune District; Hybrid; INR 500,000 - 900,000; Full time

Benefits offered by this job

Hybrid Work Model

Major medical coverage

Educational Assistance

Parental Leave

Employee Assistance Program

Job summary

Smith+Nephew invites a Design Quality Engineer to support New Product Development for hardware and software products. You will work under senior staff to develop project plans, participate in design controls and risk management, and contribute to design history files, verification, and validation activities.

The role emphasizes cross-functional collaboration, risk-based decision making, and continuous learning in a medical device environment.

Qualifications

• BS in engineering or technically related field.
• 0–3 years quality engineering experience in medical device industry.
• Familiarity with design controls and risk management.

Responsibilities

• Support quality engineering activities for NPD of hardware/software products under supervision.
• Develop risk management files, FMEA, and design controls.
• Provide quality input to product requirements and design outputs.
• Support design verification, validation, testing; protocol and test case development.
• Assist in documentation, design reviews, and audit readiness.
• Support manufacturing quality activities including MSA, incoming inspection, control plans, FMEA.

Skills

Time management

Project planning

Cross-functional collaboration

Communication skills

Accountability

Education

BS in engineering or technical field

Job description

Life Unlimited. At Smith+Nebew, we design and manufacture technology that takes the limits off living as the Design Quality Engineer your role and responsibility for supporting Quality Engineering senior staff with New Product Development activities for hardware/software products. Works under direct supervision of senior quality staff to help project team members develop and manage project plans and activities. Under direction, support design control and risk management activities for assigned projects.

Under Quality Team supervision, support new product development and implementation of new hardware/software products via development of overall risk management file. Risk management planning, use/design/software FMEA, risk control and mitigation and verification of effectiveness. (15%)

Under Quality Team supervision, support new product development of hardware/software products by participating on cross-functional core team. Provide quality input to product user needs, design inputs, software requirements, software detailed design specifications and design outputs including analysis/definition of critical to quality features. (20%)

Under Quality Team supervision, support design verification testing, design validation and usability testing. Support as needed software and/or system verification/validation testing activities including protocol and use case development, test execution and report writing. (30%)

Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities. (15%)

Under Quality Team supervision support, manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, process summaries and process FMEA. (5%)

Improve knowledge of design controls, risk management, testing, statistics, Design Verification and Validation, Measurements Systems, applicable Quality System standards/regulations and business acumen. (15%)

Education: B.S. in engineering or a technically related field
Experience: 0–3 years quality engineering experience in medical device industry

What will you need to be successful?

Time management, ability to plan and schedule multiple projects and tasks; effective collaboration with cross functional teams; effective written/oral communication skills; accountability

You Unlimited.

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

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving., Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Other reasons why you will love it here!

• Your Future: 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.

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