NPI Engineering Manager, Cardio Devices

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

Job summary

Johnson & Johnson is hiring a Manager, NPI Engineering – Circulatory Restoration for its Santa Clara, CA team. The role leads engineering staff, manages cross-functional projects, and drives product development from concept to commercial release, with a strong emphasis on catheter design and FDA/ISO compliance.

The role requires a BS in Engineering, 10+ years in medical device development, and 2+ years of people leadership.

Qualifications

• B.S. in Engineering or equivalent work experience.
• Minimum of 10 years’ progressive experience in medical device development, including 3+ years’ experience in leading projects in all phases of product development.
• 2+ years managing direct reports or equivalent experience.
• Knowledge of QSR and applicable Quality System Standards.
• Experience with disposable medical device development preferably coronary and/or vascular catheters.
• Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability.

Responsibilities

• Lead, mentor, and develop engineers and technicians.
• Oversee cross-functional projects from concept through clinical trial and commercial release.
• Guide catheter design and development activities.
• Ensure Design Control compliance with FDA/ISO/MDD requirements.
• Coordinate resources and timelines for new and improved products and manufacturing processes.
• Maintain design history files and document control records.
• Communicate milestones and issues to project team and management.
• Engage with outside vendors and contractors as needed.

Skills

Process Engineering

Leadership

Project Management

Team Management

Quality Systems

FDA/ISO Compliance

Medical Devices

Education

B.S. in Engineering

Job description

Johnson & Johnson is hiring a Manager, NPI Engineering – Circulatory Restoration for its Santa Clara, CA team. The role leads engineering staff, manages cross-functional projects, and drives product development from concept to commercial release, with a strong emphasis on catheter design and FDA/ISO compliance.

The role requires a BS in Engineering, 10+ years in medical device development, and 2+ years of people leadership.