NPD Quality Team Leader

About 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

About the Role

We are looking for a Design Quality NPI Team Leader to drive New Product Introduction (NPI) and design transfer activities from development into manufacturing. This role is critical in ensuring a smooth, efficient, and compliant transition of products and processes into production, while maintaining the highest quality standards.

You will act as the Quality focal point within cross-functional teams, influencing product development, manufacturing readiness, and process validation activities.

Key Responsibilities

NPI & Design Transfer Leadership

• Lead the transfer of new products, and major product or process changes, from R&D to production
• Ensure manufacturing readiness including testability, manufacturability, and process validation
• Drive Design for Excellence (DFx) methodologies (DFM, DFA, DFT) across development, operations, and suppliers
• Serve as a core team member in development projects, representing Quality Operations requirements
• Review and approve product and process changes (ECOs, DMR, etc.)
• Ensure compatibility and readiness of products, test equipment, and manufacturing processes

Quality Assurance & Compliance

• Ensure full compliance with relevant quality standards and regulatory requirements
• Lead process validation and verification activities, including supplier alignment and execution
• Support risk management and quality tools (e.g., FMEA, CTQs/CTXs cascading)
• Analyze production quality trends and drive improvements until product stabilization
• Apply statistical tools and data analysis to support validation and manufacturing decisions
• Perform quality control activities, including final product approval and release

Team Leadership & Development

• Lead and develop the Quality Operations NPI team
• Mentor and coach team members, promoting professional growth and skill development
• Provide training and guidance on validation, quality methodologies, and compliance requirements
• Foster a strong quality culture across the organization

Cross-Functional Collaboration

• Work closely with R&D, Operations, Suppliers, and Global Quality teams
• Communicate risks, progress, and opportunities to senior management
• Ensure alignment across stakeholders throughout the product lifecycle

Qualifications & Experience

• Bachelor's degree in Engineering or Quality (or equivalent)
• 3+ years of experience in Quality Assurance within the medical device industry
• Proven experience in NPI, design transfer, and manufacturing environments
• Experience in leading cross-functional or multidisciplinary projects

Advantage:

• Certifications such as CQE / CQM / CQA
• Experience with audits, process validation, and statistical analysis

Skills & Competencies

• Strong knowledge of quality systems, manufacturing processes, and validation methodologies
• Ability to translate quality requirements into practical procedures
• Excellent communication and presentation skills (Hebrew & English)
• Strong project management and problem-solving capabilities
• Leadership skills with experience developing and mentoring teams
• High sense of urgency and ownership
• Ability to work effectively in a matrix, cross-functional environment