Senior R&D CAPA Engineer (Hybrid) - Medical Devices

Getinge Group; Wayne (NJ); Hybride; USD 115 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health, dental, vision insurance

401k plan with company match

Paid time off

Tuition reimbursement

Résumé du poste

Getinge is seeking a Sr. Engineer, R&D CAPA in Wayne, NJ to lead complex CAPA investigations within the R&D organization.

You will guide root cause analyses, develop corrective/preventive actions, and verify effectiveness to ensure design quality and regulatory compliance. The role operates with autonomy as a technical authority, mentoring engineers on CAPA processes and regulatory expectations, while collaborating with Quality, Regulatory Affairs, and Manufacturing Engineering.

Qualifications

• CAPA experience in medical devices and product development.
• Experience with FDA regulations and ISO 13485 compliance.

Responsabilités

• Lead CAPA investigations in R&D, from problem definition through implementation and verification.
• Perform thorough root cause analyses for design, verification, validation, and product performance issues.
• Develop robust corrective and preventive actions aligned with design controls and risk management.

Connaissances

CAPA methodologies

Root cause analysis

Regulatory knowledge

Problem solving

Technical guidance

Formation

Bachelor’s degree in Engineering

Outils

TrackWise

Description du poste

Getinge is seeking a Sr. Engineer, R&D CAPA in Wayne, NJ to lead complex CAPA investigations within the R&D organization.

You will guide root cause analyses, develop corrective/preventive actions, and verify effectiveness to ensure design quality and regulatory compliance. The role operates with autonomy as a technical authority, mentoring engineers on CAPA processes and regulatory expectations, while collaborating with Quality, Regulatory Affairs, and Manufacturing Engineering.