Design Quality Engineer

Smith & Nephew•Mansfield, MA

11h•Hybrid

About The Position

Smith+Nephew is seeking a Design Quality Engineer to support its Sports Medicine Joint Repair portfolio. The role partners with cross-functional teams on sustaining engineering and product lifecycle management, helping ensure products continue to meet quality, regulatory, and business requirements and remain safe and effective for patients. The position supports lifecycle activities such as design changes, product improvements, investigations, and quality planning, and provides technical quality guidance on decisions affecting product performance, compliance, and patient safety.

Requirements

Bachelor of Science degree in Engineering or a related technical discipline.
At least 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, and CAPA and complaint handling processes.
Strong analytical, communication, collaboration, and problem-solving skills.
Ability to develop and implement solutions to complex quality challenges.
Must be currently authorized to work in the United States and must not require Smith+Nephew sponsorship now or in the future to maintain that authorization.

Nice To Haves

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

Responsibilities

Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
Lead and support risk management activities, including risk assessments, FMEAs, risk-control implementation, 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; 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 affecting product performance, compliance, and patient safety.
Drive continuous improvement using quality metrics, post-market data, and operational performance insights.