R&D Manager, Cardiovascular Medical Devices

6947-SHOCKWAVE MEDICAL INC. Legal Entity; New Brighton (MN); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson in New Brighton, Minnesota is hiring a Manager, R&D – Shockwave Medical to join our team. The role leads catheter design and development, delivering intravascular lithotripsy solutions for complex cardiovascular disease.

You will mentor engineers and manage cross-functional projects through clinical and commercial release. The position requires a strong background in medical device development, FDA/ISO design controls, and the ability to drive key milestones in a fast-paced

Qualifications

• B.S. in Engineering or equivalent work experience.
• 10+ years in medical device development with leadership.
• 2+ years directing direct reports and project leadership.
• Knowledge of QSR and Quality System Standards.
• Experience with disposable devices; coronary/vascular catheters preferred.
• Strong design for safety, reliability and manufacturability.
• Excellent communication and presentation skills; team leader.
• Experience taking products from concept through release.
• Able to work in a fast-paced environment with multiple priorities.
• Ability to lift up to 25 lbs.

Responsibilities

• Lead, mentor engineers and technicians on project teams.
• Drive cross-functional activities from concept to clinical release.
• Support catheter design and development efforts.
• Ensure design control compliance with FDA/ISO requirements.
• Coordinate resources, vendors and project timelines.
• Document development activities and maintain DHF records.
• Communicate milestones and issues to project teams and management.
• Review test methods, acceptance criteria, and equipment.
• Support clinical studies and external collaborations.

Skills

Leadership

Project management

People management

Quality systems

Medical devices

Catheters

Engineering materials

Communication skills

Product development lifecycle

Teamwork

Physical ability

Education

Engineering degree

Tools

SAP Product Lifecycle Management

Job description

Johnson & Johnson in New Brighton, Minnesota is hiring a Manager, R&D – Shockwave Medical to join our team. The role leads catheter design and development, delivering intravascular lithotripsy solutions for complex cardiovascular disease.

You will mentor engineers and manage cross-functional projects through clinical and commercial release. The position requires a strong background in medical device development, FDA/ISO design controls, and the ability to drive key milestones in a fast-paced