Design Quality Engineer - Medical Devices

Smith & Nephew; Mansfield (MA); Hybride; USD 74 000 - 112 000; Plein temps

Avantages offerts par ce poste

401k Matching

Tuition Reimbursement

Medical, Dental, Vision

Paid Holidays

Generous PTO

Volunteer Time Off

Wellness programs

Fitness club discounts

Résumé du poste

Smith+Nebhew is seeking a Design Quality Engineer to support sustaining engineering and lifecycle management for the Sports Medicine Joint Repair portfolio. You will partner with cross-functional teams to ensure products remain safe, effective, and compliant throughout their lifecycle and contribute to design controls and risk management activities.

You will collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality to drive product quality

Qualifications

• Bachelor of Science degree in Engineering or a related technical discipline.
• Minimum of 2 years of experience in the medical device industry or another regulated environment.
• Working knowledge of FDA QSR ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes.
• Strong analytical, communication, collaboration, and problem-solving skills.
• Ability to develop and implement solutions to complex quality challenges.

Responsabilités

• Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
• Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
• Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
• Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.

Formation

Bachelor of Science in Engineering

Description du poste

Smith+Nebhew is seeking a Design Quality Engineer to support sustaining engineering and lifecycle management for the Sports Medicine Joint Repair portfolio. You will partner with cross-functional teams to ensure products remain safe, effective, and compliant throughout their lifecycle and contribute to design controls and risk management activities.

You will collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality to drive product quality