NPI Engineering Manager, Circulatory Restoration

Hardware FYI; Santa Clara (CA); On-site; USD 121,000 - 209,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Johnson & Johnson, a global leader in health care, is seeking a Manager, NPI Engineering – Circulatory Restoration in Santa Clara. This role leads product and process development, mentoring engineers, and ensuring strict design control and regulatory compliance.

You will guide cross-functional teams through concept, clinical trials, and commercial release, focusing on cardiovascular catheter products. A rigorous, fast-paced environment requires strong leadership and communication skills.

Qualifications

• B.S. in Engineering or equivalent work experience.
• Minimum of 10 years’ progressive experience in medical device development.
• 3+ years’ experience leading projects through all development phases.
• 2+ years managing direct reports or equivalent experience.
• Knowledge of QSR and applicable Quality System Standards.
• Experience with disposable medical device development, preferably coronary/vascular catheters.
• Strong understanding of engineering materials, design for safety and manufacturability.
• Excellent communication and presentation skills; able to lead a team.

Responsibilities

• Lead cross-functional project activities from concept through clinical trial and commercial release.
• Mentor and support development and engineering activities, focusing on catheter design and development.
• Design and develop products and processes in compliance with Design Control and regulatory requirements.
• Coordinate technical personnel and activities for new and improved products and processes.
• Ensure documentation, lab notebooks, and design history files are complete and compliant.
• Manage outside vendors and contractors providing products or services.
• Communicate project timelines and milestones to teams and management.
• Provide regular updates on milestones and issues to project teams.

Skills

Agile decision making

Leadership

Project management

Team management

Design control

Quality systems

Communication

Problem solving

Education

B.S. in Engineering or equivalent

Job description

Johnson & Johnson, a global leader in health care, is seeking a Manager, NPI Engineering – Circulatory Restoration in Santa Clara. This role leads product and process development, mentoring engineers, and ensuring strict design control and regulatory compliance.

You will guide cross-functional teams through concept, clinical trials, and commercial release, focusing on cardiovascular catheter products. A rigorous, fast-paced environment requires strong leadership and communication skills.