Smith+NephewDesign Quality Engineer 2
Smith+Nephew is hiring a Design Quality Engineer 2 in Pune, India. Level rates it ; you can apply on Smith+Nephew.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- The posting mentions Iso 14971, Iec 62304 and Iso 13485 among its tools and skills.
- Level classes it as a mid-level role.
- Smith+Nephew has 356 other open roles on Level.
- Posted in the last few days.
AI in this role
Design Quality Engineer needed for medical device new product development, risk management, and design verification.
Life Unlimited. At Smith+Nephew, 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%)
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
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.
How we rate this
Design Quality Engineer 2 at Smith+Nephew rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where risk management was part of your work. What did you do?
- Tell me about a project where fmea was part of your work. What did you do?
- Tell me about a project where design verification was part of your work. What did you do?
- Tell me about a project where software validation was part of your work. What did you do?
- Tell me about a project where regulatory compliance was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Risk Management, Fmea, Design Verification, Software Validation, and Regulatory Compliance. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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