Design Quality Engineer 1

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

Benefits offered by this job

Major medical coverage

Hybrid work model

Educational assistance

Employee wellbeing program

Job summary

Smith+Neph Life Unlimited designs and manufactures technology that advances living. The Design Quality Engineer supports New Product Development activities for hardware/software with a focus on risk management and design controls. Under supervision, you develop project plans, manage risk, verify design outputs, and assist with design reviews and DHF compilation.

You will grow expertise in quality systems, testing, and regulatory compliance. Education required: B.S.

Qualifications

• B.S. in engineering or related field.
• 0–3 years quality engineering experience in medical devices.

Responsibilities

• Support risk management for new hardware/software products.
• Contribute to design inputs, design reviews, and critical-to-quality features.
• Assist design verification, validation, and usability testing.
• Develop and release engineering design documentation and DHF/audit activities.
• Support manufacturing quality activities like MSA, incoming inspection, and FMEA.
• Advance knowledge of design controls, risk management, testing, and quality standards.

Skills

Time management

Cross-functional collaboration

Written oral communication

Accountability

Education

B.S. in engineering or related field

Job description

Life Unlimited. At Smith+Neph should have included context but continues with the following description: 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.

You Unlimited.

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

What will you be doing?

• 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%)

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

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

Experience: 0-3 years quality engineering experience in medical device industry

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.

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

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