Design Quality Engineer: Medical Devices & Patient Safety

Smith Nephew; Mansfield (MA); Hybrid; USD 74.000 - 112.000; Vollzeit

Benefits dieser Stelle

401k Matching

Tuition Reimbursement

Paid Holidays

Flexible Time Off

Zusammenfassung

Smith+ Nephew is seeking a Design Quality Engineer in Mansfield, MA to support the Sports Medicine Joint Repair portfolio. You will partner with cross-functional teams to ensure quality, regulatory, and lifecycle requirements are met across the product lifecycle.

The role focuses on sustaining engineering, design changes, risk management, and design controls, with opportunities to influence product performance and patient safety while collaborating with Regulatory, R&D, and Manufacturing teams.

Qualifikationen

• BS degree in engineering or related technical discipline.
• At least 2 years in medical device industry or another regulated environment.
• 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.

Aufgaben

• Support product lifecycle management activities, including design changes, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, 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 impacting product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics and post-market data.

Kenntnisse

Analytical skills

Communication

Collaboration

Problem solving

Ausbildung

Bachelor of Science in engineering

Jobbeschreibung

Smith+ Nephew is seeking a Design Quality Engineer in Mansfield, MA to support the Sports Medicine Joint Repair portfolio. You will partner with cross-functional teams to ensure quality, regulatory, and lifecycle requirements are met across the product lifecycle.

The role focuses on sustaining engineering, design changes, risk management, and design controls, with opportunities to influence product performance and patient safety while collaborating with Regulatory, R&D, and Manufacturing teams.