Design Quality Engineer

Life Unlimited. At Smith+Nebhew, we design and manufacture technology that takes the limits off living. Are you passionate about quality, innovation, and patient safety? Do you enjoy working across functions to ensure medical devices remain safe, effective, and compliant throughout their lifecycle? Join Smith+Nebhew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world.

As a Design Quality Engineer, you will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.

Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization.

• Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
• Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
• Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
• Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.

• Bachelor of Science degree in Engineering or a related technical discipline.
• Minimum of 2 years of experience in the medical device industry or another regulated environment.
• Working knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes.
• Strong analytical, communication, collaboration, and problem-solving skills.
• Ability to develop and implement solutions to complex quality challenges.

• Certified Quality Engineer (CQE).
• Six Sigma certification.
• Experience supporting sustaining engineering and product lifecycle management.
• Experience participating in audits, inspections, and regulatory submissions.

Primarily seated work with occasional light lifting.

Less than 10% travel.

Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ().

• 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

• Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

• Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Hands-On, Team-Customized, Mentorship

• Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is…