R&D Manager, Cardiac MedTech & Catheter Innovation

Johnson Johnson; New Brighton (MN); Sur place; USD 117 000 - 201 000; Plein temps

Résumé du poste

Johnson & Johnson is hiring a Manager, R&D - Shockwave Medical to join our team in New Brighton, Minnesota. The role leads product and process development and manages projects across the development lifecycle in a fast-paced medical device environment.

The manager provides leadership to engineers/technicians, coordinates cross-functional activities, and ensures compliance with FDA/ISO/QSR requirements while driving timely delivery and robust documentation.

Qualifications

• Bachelor's degree in engineering or equivalent work experience.
• Minimum 10 years of progressive experience in medical device development.
• 3+ years of experience leading projects across all phases of 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/vascular catheters.

Responsabilités

• 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 in compliance with Design Control, FDA, ISO and MDD requirements.
• Coordinate technical personnel and their activities for new and improved products and processes.
• Ensure development documentation is properly maintained in lab notebooks and history files.
• Communicate project milestones and issues to team and management.
• Coordinate and manage outside vendors and contractors.

Connaissances

Leadership

Project management

Communication

Team mentoring

Regulatory experience

Formation

B.S. in Engineering

Description du poste

Johnson & Johnson is hiring a Manager, R&D - Shockwave Medical to join our team in New Brighton, Minnesota. The role leads product and process development and manages projects across the development lifecycle in a fast-paced medical device environment.

The manager provides leadership to engineers/technicians, coordinates cross-functional activities, and ensures compliance with FDA/ISO/QSR requirements while driving timely delivery and robust documentation.