Design Quality Engineer 1

Smith & Nephew; Pune District; Hybrid; INR 600,000 - 900,000; Full time

Benefits offered by this job

Hybrid work model

Major medical coverage

Educational assistance

Work/Life balance

Wellbeing program

Training

Job summary

Smith+Nephew is seeking a Design Quality Engineer to support New Product Development by contributing to risk management for hardware and software products. You will work under senior staff to help plan, execute, and document quality activities across design controls and verification/validation.

Responsibilities include developing risk management files, supporting cross-functional teams, and assisting with design history files and audits. Hybrid work model and healthcare benefits are offered.

Qualifications

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

Responsibilities

• Support new product development and create risk management files for hardware/software products.
• Provide quality input to user needs, design inputs, software requirements, and design outputs.
• Support design verification testing, design validation, and usability testing.
• Develop and release engineering design documentation, support design reviews and audit activities.
• Support manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, and FMEA.
• Improve knowledge of design controls, risk management, testing, statistics, and related standards.

Skills

Risk management

FMEA

Design controls

Verification & validation

Cross-functional collaboration

Education

B.S. in engineering

Job description

Life Unlimited. At Smith+Nephew, 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.

You Unlimited.

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%)

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

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/).

• 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! Follow us on LinkedIn to see how we support and empower our employees and patients every day. 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.

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.