Senior Design Quality Engineer
Smith+Nephew
Summary
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.
Job description
What will you be doing?
- 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
What will you need to be successful?
- 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
- CQE and/or Six Sigma certification preferred
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
- CQE and/or Six Sigma certification preferred
Benefits
- 401(k) Matching
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible Time Off
- Paid Holidays
- Medical, Dental & Vision
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility & Adoption Assistance
- Hybrid Work Model
- Fitness Club Discounts
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.