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

Tuition Reimbursement

Hybrid Work Model

Medical/Dental/Vision

Job summary

Smith+ Nephew in Mansfield, MA is seeking a Senior Design Quality Engineer to support sustaining and lifecycle management for Sports Medicine Joint Repair products. You will ensure safety, effectiveness, compliance, and alignment with patient and clinician needs.

Based in Mansfield, MA, you will partner with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, and Supplier Quality to drive design quality improvements and risk controls across the product lifecycle.

Qualifications

• Bachelor of Science degree in Engineering or related field.
• 5+ years in medical device or regulated environment.
• Experience with risk management, design controls, change control, CAPA and lifecycle management.

Responsibilities

• Serve as Design Quality representative for product support and lifecycle activities.
• Lead risk management activities including FMEA and verification of effectiveness.
• Provide design quality oversight for design verifications, validations, sterilization and test methods.
• Lead investigations related to complaints, nonconformances, CAPAs, and post-market surveillance.
• Review/approve quality and engineering documentation per design controls and quality system requirements.
• Collaborate with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality.
• Act as a quality engineering resource for complex technical/compliance issues.
• Drive continuous improvement through quality data analysis and performance metrics.
• Provide technical leadership, training, and mentorship.

Skills

Design Quality

Risk Management

Design Verification

Validation

CAPA

Documentation Review

Cross-functional Collaboration

Regulatory Submissions

Education

Bachelor of Science in Engineering

Tools

FMEA

CAPA System

Quality System

Job description

Smith+ Nephew in Mansfield, MA is seeking a Senior Design Quality Engineer to support sustaining and lifecycle management for Sports Medicine Joint Repair products. You will ensure safety, effectiveness, compliance, and alignment with patient and clinician needs.

Based in Mansfield, MA, you will partner with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, and Supplier Quality to drive design quality improvements and risk controls across the product lifecycle.