Senior Design Quality Engineer - MedTech Quality Leader

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

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Paid Holidays

Flex Personal/Vacation Time Off

Hybrid Work Model

Employee Assistance Program

Job summary

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

You will lead risk management, design controls, verification/validation, CAPA, and post‑market activities, while collaborating with Regulatory Affairs, Operations, R&D, and suppliers.

Qualifications

• Bachelor of Science degree in Engineering or a technically related field.
• 5+ years in the medical device industry or a similarly regulated environment.
• 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.

Responsibilities

• Serve as the Design Quality representative for product support and lifecycle activities.
• Lead risk management activities including risk assessments, FMEA, control implementation, and verification of effectiveness.
• Provide design quality oversight for design verification and validation activities, sterilization validations, process validations, supplier qualifications, and manufacturing changes.
• Lead or support investigations related to complaints, nonconformances, CAPAs, post-market surveillance, and trend analyses to drive corrective actions.
• Review and approve quality and engineering documentation to ensure compliance with design controls and quality system requirements.
• Partner with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality to support regulatory submissions, audits, and inspections.

Skills

Risk management

Design controls

CAPA

Validation

Cross-functional collaboration

Problem solving

Communication skills

Six Sigma

Education

BSc in Engineering

Job description

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

You will lead risk management, design controls, verification/validation, CAPA, and post‑market activities, while collaborating with Regulatory Affairs, Operations, R&D, and suppliers.