R&D Manager, MedTech: Lead Catheter Innovation

Shockwave Medical, Inc.; New Brighton (MN); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation 120 hours per year

Sick time 40 hours per year

Holiday pay 13 days per year

Parental Leave 480 hours per year

Volunteer Leave 32 hours per year

Job summary

Johnson & Johnson is hiring a Manager, R&D – Shockwave Medical to join our team in New Brighton, Minnesota. This role leads engineering teams in intravascular lithotripsy development, aligning design control with FDA/ISO standards while guiding product maturation from concept to market.

You will coordinate multi-disciplinary activities, manage timelines, and collaborate with vendors and clinical teams to ensure high-quality, safe, and effective cardiovascular devices for patients.

Qualifications

• BS in Engineering or equivalent work experience.
• 10+ years progressive medical device development experience.
• 3+ years leading projects through all product development phases.
• 2+ years managing direct reports.
• Knowledge of QSR and Quality System Standards.
• Experience with disposable medical device development, preferably catheters.

Responsibilities

• Lead cross-functional project activities from concept through clinical trial and commercial release.
• Mentor development and engineering activities focused on catheter design.
• Ensure compliance with Design Control requirements and regulatory standards.
• Coordinate external vendors and assess manufacturability of new products.
• Develop and communicate project timelines and milestones.
• Review and approve test methods, acceptance criteria, and equipment.
• Interact with clinical teams for feedback and validation activities.

Skills

Engineering leadership

Project management

Catheter development

Cross-functional coordination

Design control

Communication skills

Clinical/research coordination

Education

B.S. in Engineering

Tools

SAP Product Lifecycle Management

Job description

Johnson & Johnson is hiring a Manager, R&D – Shockwave Medical to join our team in New Brighton, Minnesota. This role leads engineering teams in intravascular lithotripsy development, aligning design control with FDA/ISO standards while guiding product maturation from concept to market.

You will coordinate multi-disciplinary activities, manage timelines, and collaborate with vendors and clinical teams to ensure high-quality, safe, and effective cardiovascular devices for patients.