Senior Design Quality Engineer, Med Devices (Hybrid)

smithnephew; Mansfield (MA); Hybrid; USD 97,000 - 120,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Paid Holidays

Volunteer time off

Wellbeing programs

Job summary

Smith+Naphew in Mansfield, MA is seeking a Senior Design Quality Engineer to support sustaining and lifecycle management of Sports Medicine Joint Repair products. You will partner across Regulatory, Operations, R&D and Manufacturing to ensure safety, compliance and continuous quality improvement.

The role requires a BS in Engineering, 5+ years in a regulated med device setting, and strong knowledge of QSR/ISO standards with hands-on risk management, design controls, CAPA, and validation

Qualifications

• Bachelor of Science in Engineering or related field.
• 5+ years in the medical device industry or a regulated environment.
• Knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements.
• Experience with risk management, design controls, change control, CAPA, validation, and product lifecycle management.
• 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.

Responsibilities

• Serve as the Design Quality representative for product support and lifecycle management activities.
• Lead risk management activities including risk assessments and FMEA development/maintenance.
• Provide design quality oversight for design verification/validation activities, sterilization validations, process validations, supplier qualifications, manufacturing changes, and test methods.
• Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments.
• Review and approve quality and engineering documentation to ensure design controls, change control, risk management and quality system compliance.
• Collaborate with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality for regulatory submissions and audits.
• Act as a quality engineering resource for complex technical and compliance issues, guiding decisions impacting quality, patient safety and business goals.
• Identify and drive continuous improvement opportunities through quality data, feedback, risk outputs, and metrics.
• Provide technical leadership, training, and mentorship to support decision making and quality excellence.

Skills

Design quality

Risk management

CAPA

Change control

Validation

Regulatory knowledge

Root cause analysis

Documentation

Quality systems

Leadership

Education

Bachelor of Science in Engineering

Job description

Smith+Naphew in Mansfield, MA is seeking a Senior Design Quality Engineer to support sustaining and lifecycle management of Sports Medicine Joint Repair products. You will partner across Regulatory, Operations, R&D and Manufacturing to ensure safety, compliance and continuous quality improvement.

The role requires a BS in Engineering, 5+ years in a regulated med device setting, and strong knowledge of QSR/ISO standards with hands-on risk management, design controls, CAPA, and validation