Senior Design Quality Engineer

Smith & Nephew•Mansfield, MA

6d•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Do you thrive in a collaborative environment where innovation, quality, and patient safety are at the heart of everything you do? As a Senior Design Quality Engineer, you will play a critical role in supporting the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring they remain safe, effective, compliant, and aligned with the needs of both patients and healthcare professionals. Based in Mansfield, MA, this is an opportunity to influence product quality, drive continuous improvement, and partner with cross functional teams to make a meaningful impact.

Requirements

Bachelor of Science degree in Engineering or a technically related field
5+ years of experience in the medical device industry or another highly regulated environment
Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements
Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders
Excellent communication, collaboration, and problem solving skills

Nice To Haves

CQE and/or Six Sigma certification preferred

Responsibilities

Serve as the Design Quality representative for product support and lifecycle management activities, including product improvements, design changes, quality planning, investigations, and continuous quality enhancement initiatives
Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness
Provide design quality oversight and approval for design verification and validation activities, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods
Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective and preventive actions
Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system requirements
Partner closely with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality teams to support regulatory submissions, audits, inspections, and ongoing product support
Act as a quality engineering resource for complex technical and compliance related issues, providing guidance and influencing decisions that impact product quality, patient safety, and business objectives
Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and operational performance metrics
Provide technical leadership, training, guidance, and mentorship to support effective decision making, accountability, compliance, and quality excellence