NPD Quality & Compliance Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Yokneam, Haifa District, Israel

Job Description:

About Johnson & Johnson MedTech Cardiovascular:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for an NPD Quality & Compliance Engineer role, to join our team located in Yokneam, Israel.

You will be responsible for:

Support R&D Design activities throughout the 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 standards

Lead quality improvements for product and processes

Support Internal and External Audits

Qualifications and Requirements:

Bachelor's Degree in engineering or equivalent – Required

At least 3 years of experience in the Medical Device industry – Required

Knowledge of medical devices standards and regulation (EU MDD/ MDR, CFR 820, ISO13845, ISO14971 etc.) – Required

Critical thinking and investigation skills – Required

Experience in Medical Device NPD/NPI – Advantage

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

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