Manager, NPI Engineering - Circulatory Restoration

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Manager, NPI Engineering – Circulatory Restoration to join our team located in Santa Clara, CA.

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Position Overview

The Manager, NPI Engineering provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives

Essential Job Functions

• Manage, lead, and mentor engineer(s) and/or technician(s).
• Lead all cross-functional project activities from concept through clinical trial and commercial release of product.
• Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development.
• Design and develop products and processes in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
• Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, history file, Engineering Reports and other records.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services.
• Create, maintain, and communicate project timelines for internal and outside development projects.
• Provide regular updates of key milestones and issues to the project team as well as management.
• Identify issues and recommend solutions for products in development.
• Contribute ideas to new product development, as defined by product specification, process development, and manufacturing technologies.
• Approve test methods, acceptance criteria, and test equipment for all stages of product development.
• Review and approve documents as specified in Document Control SOP.
• Compile the Design History File and conduct design reviews in compliance with Design control procedures.
• Ensure that products have capable manufacturing processes and that process verifications and validations are completed.
• Interact with cross-functional groups to ensure that products and processes are compatible with other products and processes in the intended operating system, and have met all requirements per design control process.
• Other duties as assigned.
• Provide technical leadership for projects, including managing process and technology development teams.
• Maintain up-to-date knowledge of competitive technologies and biomedical developments relevant to the company’s products.
• Ensures that products and processes satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
• Support company goals, policies, procedures, quality systems, and compliance with FDA and other regulatory bodies.

Requirements

• 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.

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