Skip to main content


NPD Quality Engineer Class III

  • Job Title NPD Quality Engineer Class III
  • Function Quality
  • Sub Function Quality Assurance
  • Location Yokneam, Northern, Israel
  • Date Posted
  • Requisition Number 2406165507W
Apply Now


We at Biosense are looking for a NPD Quality & Compliance Engineer for an innovative new project.  In this role you will: 

• Lead R&D Design activities throughout New Product Introduction & during Product Development process 
• Managing Project DHF and providing status to the Project management 
• Provide quality inputs for new or modified products development 
• Accountable for the Product Risk Management process throughout the PDP
• Support the Design Change process by reviewing the change and performing impact assessments with the team
• Participate and approve the Product Design Reviews 
• Review and approval of the Product DHF documents 
• Write, review, and implement quality procedures
• Verify the product complies with applicable internal and external standards
• Drive continues improvements in product quality and manufacturing processes, working with and R&D &  CM to identify and resolve quality gaps

• Act as a primary contact for escalating manufacturing & quality issues identified by CM.

• Lead and contact Root Cause analysis and develop reports on manufacturing defects from customer feedback & internal findings according to internal QMS

• Support Internal and External Audits



• Bachelor's Degree in engineering or equivalent – Required
• At least 3 years of experience in the Medical Device industry, specific in NPD/NPI – Required
• Knowledge of medical devices standards and regulation (EU MDD/ MDR, CFR 820, ISO13845,  ISO14971 etc.) – Required
• Critical thinking and investigation skills – Required 

•Effective communication & collaboration skills to cooperate with Design Engineers, manufacturing teams and other stakeholders
• CQE/ ICQE – Advantage
• Demonstrated scientific analysis abilities – Major Advantage 
• Internal/lead auditing certificate – Advantage
• Familiar with general QMS concepts, including GDP, CAPA, and document change control practices
• Strong written and verbal communication skills in English 

• Strong documentation skills for review quality documents and Quality records. 

Your next move could mean our next breakthrough.

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

Join now