Senior Design Quality Engineer — Medical Devices (Hybrid)

Smith & Nephew; Mansfield (MA); Hybrid; USD 97,000 - 120,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Medical, Dental, Vision insurance

Job summary

Smith+Neu in Mansfield, MA is seeking a Senior Design Quality Engineer to support the sustaining and lifecycle management of Sports Medicine Joint Repair products. You will partner with Regulatory Affairs, Operations, R&D, and Manufacturing to drive quality excellence and ensure patient safety.

The role requires a BS in Engineering and 5+ years in medical devices or regulated spaces, with strong knowledge of QSR, ISO 13485, and ISO 14971.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years in medical device or highly regulated environment.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.

Responsibilities

• Serve as Design Quality representative for product support, lifecycle management, and quality improvement initiatives.
• Lead risk management activities including FMEA, risk controls, and verification of effectiveness.
• Provide design quality oversight for verification/validation activities and supplier qualifications.
• Lead investigations related to complaints, nonconformances, CAPAs, and post-market surveillance.
• Review and approve quality and engineering documentation for compliance with design controls and change control.

Skills

Risk management

Design quality

Cross-functional collaboration

Quality systems knowledge

CAPA & validation

Problem solving

Communication skills

Education

Bachelor of Science in Engineering

Job description

Smith+Neu in Mansfield, MA is seeking a Senior Design Quality Engineer to support the sustaining and lifecycle management of Sports Medicine Joint Repair products. You will partner with Regulatory Affairs, Operations, R&D, and Manufacturing to drive quality excellence and ensure patient safety.

The role requires a BS in Engineering and 5+ years in medical devices or regulated spaces, with strong knowledge of QSR, ISO 13485, and ISO 14971.