SW Quality Engineer (MedTech)

Location: Yokneam, Haifa District, Israel; primary location is the Yokneam site. Full-time onsite role; travel may be required based on business needs.

Company

A global healthcare organization developing cardiovascular and other MedTech solutions, including treatments for heart recovery, electrophysiology, and stroke.

What you will do

• Conduct software-related product complaint investigations with R&D, Software Engineering, QA, Compliance, Service, and Complaints teams.
• Review complaint information and additional evidence, including logs, configurations, test evidence, and code analysis.
• Assess potential quality, safety, and compliance impact and escalate complaints with regulatory implications.
• Facilitate root cause analysis for software defects and customer complaints.
• Document findings, root cause conclusions, and recommended corrective and preventive actions.
• Analyze complaint trends, support audits, and improve complaint-handling and investigation processes.

Requirements

• BA degree or Practical Engineering diploma required; BSc is an advantage.
• Experience in a medical device environment.
• Knowledge of software lifecycle and quality principles, complaint investigations, and post-market activities.
• Working knowledge of IEC 62304, ISO 13485, and ISO 14971, or the ability to learn them quickly.
• Experience with defect tracking and requirements management tools such as Azure DevOps/VSTS or Polarion.
• High-level English proficiency is required, together with strong analytical, critical-thinking, communication, ownership, and attention-to-detail skills.

Culture & Benefits

• Work within a Quality Assurance organization focused on patient safety and product quality.
• Collaborate with cross-functional teams across software engineering, quality, compliance, service, and complaints.
• Contribute to continuous improvement by feeding investigation lessons into product and process improvements.
• Work independently and as part of a team in an inclusive environment.