Design Quality Engineer 2

Smith & Nephew; Pune District; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Major medical coverage

Educational Assistance

Work/Life Balance: Flexible Personal/V

Vacation Time Off

Parental Leave

Training: Hands-On

Hybrid Work Model

Employee Assistance Program

Job summary

Smith & Nephew in Pune invites a Quality/Regulatory Engineer to join Life Unlimited initiative and contribute to risk management, V&V, design control and regulatory submissions.

You will collaborate cross-functionally on NPD, verify and validate software to IEC 62304, and help compile design history files and audit documentation in a hybrid work setting.

Qualifications

• 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

Responsibilities

• Risk management file development and mitigation activities
• Cross-functional NPD support and design input/outputs
• Design verification, validation and usability testing; V&V including protocol/use case development and test reports
• Development and release of engineering design documentation and DHF/audit support
• Manufacturing quality activities including MSA, incoming inspection, control plans
• Regulatory submission preparation and audit/inspection support

Education

B.S. in engineering or technically related field

Job description

Life Unlimited. At Smith+Neb??

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

Benefits

• Major medical coverage + policy exclusions and insurance non-medical limit.
• Educational Assistance.
• Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave.
• Parents/Parents-in-Law’s Insurance (Employer Contribution of 8,000/- annually)
• Employee Assistance Program
• Parental Leave.
• Training: Hands-On, Team-Customized, Mentorship.
• Flexibility: Hybrid Work Model (For most professional roles)

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. 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+Neb 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+Neb 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.